Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial

Background

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) comprises the administration of heated, humidified, and blended air/oxygen mixtures via nasal cannula at rates of ≥2 litres kg^?1 min^?1. The aim of this randomized controlled study was to evaluate the length of the safe apnoea time using THRIVE with two different oxygen concentrations (100% vs 30% oxygen) compared with standard low-flow 100% oxygen administration.

A physiological study to determine the mechanism of carbon dioxide clearance during apnoea when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE)

Clinical observations suggest that compared with standard apnoeic oxygenation, transnasal humidified rapid-insufflation ventilatory exchange using high-flow nasal oxygenation reduces the rate of carbon dioxide accumulation in patients who are anaesthetised and apnoeic. This suggests that active gas exchange takes place, but the mechanisms by which it may occur have not been described. We used three laboratory airway models to investigate mechanisms of carbon dioxide clearance in apnoeic patients. We determined flow patterns using particle image velocimetry in a two-dimensional model using particle-seeded fluorescent solution; visualised gas clearance in a three-dimensional printed trachea model in air; and measured intra-tracheal turbulence levels and carbon dioxide clearance rates using a three-dimensional printed model in air mounted on a lung simulator. Cardiogenic oscillations were simulated in all experiments. The visualisation experiments indicated that gaseous mixing was occurring in the trachea. With no cardiogenic oscillations applied, mean (SD) carbon dioxide clearance increased from 0.29 (0.04) ml.min⁻¹ to 1.34 (0.14) ml.min⁻¹ as the transnasal humidified rapid-insufflation ventilatory exchange flow rate was increased from 20 l.min⁻¹ to 70 l.min⁻¹ (p = 0.0001). With a cardiogenic oscillation of 20 ml.beat⁻¹ applied, carbon dioxide clearance increased from 11.9 (0.50) ml.min⁻¹ to 17.4 (1.2) ml.min⁻¹ as the transnasal humidified rapid-insufflation ventilatory exchange flow rate was increased from 20 l.min⁻¹ to 70 l.min⁻¹ (p = 0.0014). These findings suggest that enhanced carbon dioxide clearance observed under apnoeic conditions with transnasal humidified rapid-insufflation ventilatory exchange, as compared with classical apnoeic oxygenation, may be explained by an interaction between entrained and highly turbulent supraglottic flow vortices created by high-flow nasal oxygen and cardiogenic oscillations.     

Measurement of airway pressure during high-flow nasal therapy in apnoeic oxygenation: a randomised controlled crossover trial*

It is recognised that high-flow nasal therapy can prevent desaturation during airway management. Studies in spontaneously breathing patients show an almost linear relationship between flow rate and positive airway pressure in the nasopharynx. Positive airway pressure has been suggested as one of the possible mechanisms explaining how high-flow nasal therapy works. However, data on pressures generated by high-flow nasal therapy in apnoeic adults under general anaesthesia are absent. This randomised controlled crossover trial investigated airway pressures generated by different flow rates during high-flow nasal therapy in anaesthetised and paralysed apnoeic patients, comparing pressures with closed and open mouths. Following induction of anaesthesia and neuromuscular blockade, a continuous jaw thrust was used to enable airway patency. Airway pressure was measured in the right main bronchus, the middle of the trachea and the pharynx, using a fibreoptically-placed catheter connected to a pressure transducer. Each measurement was randomised with respect to closed or open mouth and different flow rates. Twenty patients undergoing elective surgery were included (mean (SD) age 38 (18) years, BMI 25.0 (3.3) kg.m^-2, nine women, ASA physical status 1 (35%), 2 (55%), 3 (10%). While closed mouths and increasing flow rates demonstrated non-linear increases in pressure, the pressure increase was negligible with an open mouth. Airway pressures remained below 10 cmH₂O even with closed mouths and flow rates up to 80 l.min⁻¹; they were not influenced by catheter position. This study shows an increase in airway pressures with closed mouths that depends on flow rate. The generated pressure is negligible with an open mouth. These data question positive airway pressure as an important mechanism for maintenance of oxygenation during apnoea.     

Oral to nasal tube exchange under fibroscopic view: a new technique for nasal intubation in a predicted difficult airway

For a predicted difficult airway, oral intubation techniques are well established in pediatric anesthesia, but nasotracheal intubation remains a problem. There are many reports concerning this, but the risk of bleeding, added to the lack of cooperation make this procedure difficult and hazardous. We describe a modification of the nasal intubation technique in two stages. First an oral intubation and then exchanging the oral for a nasal tube, in the case of a 13-year-old boy affected by an advanced stage of cherubism. Oral intubation using a laryngeal mask technique has already been reported, but problems appear during the exchange procedure and even more when direct laryngoscopy is impossible. Fiberscopic control of the exchange, and the introduction of a Cook Exchange Catheter into the trachea through the oral tube before withdrawal, permits oxygenation of the patient and acts as a guide for oral tube reintroduction if required.     

High-flow nasal oxygen vs. standard flow-rate facemask pre-oxygenation in pregnant patients: a randomised physiological study

High-flow nasal oxygen has been shown to provide effective pre-oxygenation and prolong apnoeic time during intubation attempts in non-pregnant patients. We aimed to compare pre-oxygenation using high-flow nasal oxygen (30–70 l.min⁻¹ oxygen flow) via nasal prongs with standard 15 l.min⁻¹ oxygen breathing via a tight-fitting facemask. Forty healthy parturients were randomly allocated to these two groups, and furthermore each patient underwent the selected pre-oxygenation method with both 3-min tidal volume breathing and 30s tidal breathing followed by eight vital capacity breaths. With 3-min tidal volume breathing, the respective estimated marginal means for high-flow nasal oxygen and standard flow rate facemask pre-oxygenation were 87.4% (95%CI 85.5–89.2%) and 91.0% (95%CI 89.3–92.7%), p = 0.02; with eight vital capacity breaths the estimated marginal means were 85.9% (95%CI 84.1–87.7%) and 91.8% (95%CI 90.1–93.4%, p < 0.0001). Furthermore, high-flow nasal oxygen did not reliably achieve a mean end-tidal oxygen concentration ≥ 90% compared with the standard flow rate facemask. In this physiological study, high-flow nasal oxygen pre-oxygenation performed worse than standard flow rate facemask pre-oxygenation in healthy term parturients.     

Use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) to facilitate the management of subglottic stenosis in pregnancy

Subglottic stenosis is a rare condition. Diagnosis is often delayed as symptoms are attributed to other causes, such as asthma. This problem may be compounded in pregnancy when dyspnoea may be attributed to normal physiological changes. In respiratory compromise, surgical intervention may be required and airway management is challenging as endotracheal intubation may be traumatic or, in severe cases, impossible.Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) is a novel open-airway apnoeic technique using high-flow nasal oxygen. It does not expose the patient to the risks of jet ventilation, nor does it require the placement of an airway device to effectively oxygenate the patient. In pregnancy, elevation of maternal carbon dioxide is of particular concern as it may result in a worsening fetal acidosis. While THRIVE has been shown to provide some clearance of carbon dioxide, a patent airway is required for it to function effectively.In this case report we describe the management of a pregnant patient who underwent balloon dilatation for severe subglottic stenosis at 23 weeks’ gestation using THRIVE and we summarise the evidence supporting the use of this new technique in pregnant women.     

A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre‐oxygenation with facemask pre‐oxygenation in patients undergoing rapid sequence induction of anaesthesia

Pre‐oxygenation is an essential part of rapid sequence induction of general anaesthesia for emergency surgery, in order to increase the oxygen reservoir in the lungs. We performed a randomised controlled trial of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre‐oxygenation or facemask pre‐oxygenation in patients undergoing emergency surgery. Twenty patients were allocated to each group. No patient developed arterial oxygen saturation < 90% during attempted tracheal intubation. Arterial blood gases were sampled from an arterial catheter immediately after intubation. The mean (SD) PaO₂ was 43.7 (15.2) kPa in the THRIVE group vs. 41.9 (16.2) kPa in the facemask group (p = 0.722); PaCO₂ was 5.8 (1.1) kPa in the THRIVE group vs. 5.6 (1.0) kPa in the facemask group (p = 0.631); arterial pH was 7.36 (0.05) in the THRIVE group vs. 7.34 (0.06) in the facemask group (p = 0.447). No airway rescue manoeuvres were needed, and there were no differences in the number of laryngoscopy attempts between the groups. In spite of this, patients in the THRIVE group had a significantly longer apnoea time of 248 (71) s compared with 123 (55) s in the facemask group (p < 0.001). Transnasal humidified rapid insufflation ventilatory exchange is a practicable method for pre‐oxygenating patients during rapid sequence induction of general anaesthesia for emergency surgery; we found that it maintained an equivalent blood gas profile to facemask pre‐oxygenation, in spite of a significantly longer apnoea time.     

不同流速经鼻湿化快速充气通气联合无创通气对肥胖患者全麻诱导期胃进气的影响

目的 通过胃窦超声检查评估不同流速经鼻湿化快速充气通气（THRIVE）联合无创通气（NIV）在全麻诱导时对肥胖患者胃进气的影响。
方法 选择择期全麻手术患者72例,男29例,女43例,年龄18～64岁,BMI 30.0～39.9 kg/m²,ASA Ⅰ或Ⅱ级。随机分为三组：H30组、H50组、H70组,每组24例。三组均行THRIVE 30 L/min预给氧5 min后行全麻诱导。全麻诱导后三组分别接受相应氧流量大小（30、50、70 L/min,FiO₂ 100%）的THRIVE联合NIV（10 cmH₂O）行压力控制给氧。气管插管期,各组继续行对应流速THRIVE以提供窒息氧合。入室时以及诱导通气结束时,采用超声监测患者仰卧位胃窦部进气情况,超声图像出现“彗尾征”则定义为胃进气阳性（GI⁺）。记录全麻诱导期GI⁺的发生情况;记录入室时以及诱导通气结束时的胃窦部横截面积（CSA）;记录插管过程中SpO₂最低值以及诱导通气结束时PaO₂、PaCO₂、P_ETCO₂等呼吸参数;记录术后恶心呕吐、反流误吸、鼻咽部不适和气压伤等不良事件的发生情况。
结果 全麻诱导期H70组GI⁺发生率明显高于H30组、H50组（P<0.05）。与入室时比较,诱导通气结束时H70组胃窦部CSA明显增大（P<0.05）。诱导通气结束时H70组CSA明显大于与H30组、H50组（P<0.05）。插管过程中H50组、H70组SpO₂最低值明显高于H30组（P<0.05）;诱导通气结束时H50组、H70组PaO₂明显高于H30组,PaCO₂明显低于H30组（P<0.05）。三组恶心呕吐发生率差异无统计学意义。三组均无一例反流误吸、鼻咽部不适和气压伤。
结论 THRIVE 50 L/min联合NIV 10 cmH₂O压控给氧能为肥胖患者全麻诱导期提供较好的氧合,且明显降低胃进气发生率。     

Transnasal humidified rapid‐insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre‐oxygenation for rapid sequence induction in adults: a prospective randomised non‐blinded clinical trial

Transnasal humidified rapid‐insufflation ventilatory exchange (THRIVE) can prolong apnoea time in adults. Therefore, THRIVE used for pre‐oxygenation in rapid sequence induction of anaesthesia could extend safe apnoea time during prolonged laryngoscopy and intubation. In this randomised controlled trial, we compared the lowest peripheral oxygen saturation (SpO₂) during intubation when pre‐oxygenating with either traditional facemask or THRIVE. Eighty adult patients, undergoing rapid sequence induction of anaesthesia for emergency surgery, were randomly allocated to pre‐oxygenation with 100% oxygen with facemask or with THRIVE. Median (IQR [range]) lowest SpO₂ until 1 min after intubation was 99% (97–100 [70–100]%) for the facemask group vs. 99% (99–100 [96–100]%) for the THRIVE group (p = 0.097). Five patients (12.5%) desaturated below 93% when pre‐oxygenated with the facemask vs. none in the THRIVE group (p = 0.019). There were no differences in intubation time or apnoea time between the groups. Median intubation time was 51 (34–66 [22–261]) s in the facemask group vs. 48 (38–63 [10–146]) s in the THRIVE group (p = 0.99). Median apnoea time was 109 (86–142 [37–291]) s and 116 (92–146 [63–249]) s when using facemask and THRIVE, respectively (p = 0.49). No signs of regurgitation of gastric content were detected. The data on desaturation indicate potential benefits of oxygenation with THRIVE for rapid sequence induction compared with facemask pre‐oxygenation.     

High inspired oxygen fraction impairs lung volume and ventilation heterogeneity in healthy children: a double-blind randomised controlled trial

Background

Although a high inspired oxygen fraction (FiO₂) is commonly used in paediatric anaesthesia, the impact on postoperative lung function is unclear. We compared lung volume, ventilation heterogeneity, and respiratory mechanics in anaesthetised children randomised to receive low or high FiO₂ intraoperatively.

The performance of rigid scopes for tracheal intubation: a randomised,controlled trial in patients with a simulated difficult airway

We compared the Bonfils^? and SensaScope^? rigid fibreoptic scopes in 200 patients with a simulated difficult airway randomised to one of the two devices. A cervical collar inhibited neck movement and reduced mouth opening to a mean (SD) of 23 (3) mm. The primary outcome parameter was overall success of tracheal intubation; secondary outcomes included first‐attempt success, intubation times, difficulty of intubation, fibreoptic view and side‐effects. The mean (95% CI) overall success rate was 88 (80–94)% for the Bonfils and 89 (81–94)% for the SensaScope (p = 0.83). First‐attempt intubation success rates were 63 (53–72)% for the Bonfils and 72 (62–81)% for the SensaScope (p = 0.17). Median (IQR [range]) intubation time was significantly shorter with the SensaScope (34 (20–84 [5–240]) s vs. 45 (25–134 [12–230]) s), and fibreoptic view was significantly better with the SensaScope (full view of the glottis in 79% with the SensaScope vs. 61% with the Bonfils). This might be explained by its steerable tip and the S‐formed shape, contributing to better manoeuvrability. There were no differences in the difficulty of intubation or side‐effects.     

Evaluation of three unchannelled videolaryngoscopes and the Macintosh laryngoscope in patients with a simulated difficult airway: a randomised,controlled trial

This prospective randomised, controlled trial compares the performance of three unchannelled videolaryngoscopes (KingVision^?, Airtraq^?, A.P. Advance^? MAC ) and the standard Macintosh laryngoscope. With ethics committee approval and written informed consent, 480 patients were included. A difficult airway was created with a cervical collar, limiting mouth opening and neck movement. Primary outcome was first‐attempt orotracheal intubation success. Overall success, laryngeal view, intubation difficulty scale, handling, intubation times and side‐effects were secondary outcomes. First‐attempt success rates were: KingVision 90% (95% CI 83–94%), Airtraq 82% (74–88%), A.P. Advance MAC 49% (40–58%), Macintosh 44% (35–53%; p < 0.001). The 95% confidence interval of first‐attempt success rate was thus below 90% for all devices, but the KingVision and the Airtraq performed better than the A.P. Advance MAC and the Macintosh laryngoscope. Also, performance was better with the KingVision and the Airtraq in terms of overall success, laryngeal view, intubation difficulty scale and quality of view. Problems with tube advancement were a frequent cause of intubation failure. In summary, the KingVision and the Airtraq performed better than the A.P. Advance MAC and the Macintosh laryngoscope. Success rates of the unchannelled KingVision and Airtraq were similar to those of their channelled versions reported previously, indicating that performance largely depends on blade design rather than the presence of a channel for tube advancement.     

Nasotracheal intubation over a bougie vs. non‐bougie intubation: a prospective randomised,controlled trial in older children and adults using videolaryngoscopy

Conventionally, nasotracheal intubation has consisted of blind nasal passage and external manipulation of the tube through the glottis (‘conventional technique’), a technique associated with a high incidence of nasal trauma. We evaluated a novel technique for routine asleep (i.e. post‐induction) nasotracheal intubation using a bougie (‘bougie technique’), which uses a nasopharyngeal airway to guide a paediatric bougie nasotracheally for use as a Seldinger tracheal intubation guide. Two hundred and fifty‐seven older children (> 8 years) and adults were randomly assigned to videolaryngoscopy‐assisted nasotracheal intubation using either the conventional or the bougie technique. The hypothesis was that the bougie technique would result in less nasopharyngeal trauma. The bougie technique was associated with significantly less nasopharyngeal bleeding than the conventional technique at both 60–90 s (55% vs. 68%; p = 0.033) and 5 min (51% vs. 70%; p = 0.002). The severity of bleeding was also significantly less with the bougie technique, with an OR for active bleeding of 0.42 (95%CI 0.20–0.87; p = 0.020) at 60–90 s and 0.15 (95%CI 0.06–0.37; p < 0.0001) at 5 min. Magill forceps were needed significantly less often with the bougie technique (9% vs. 28%, p = 0.0001) and there was no difference in first attempt and overall success rates between the two techniques (p = 0.133 and p = 0.750, respectively). Not only is nasal intubation over a bougie as successful as the conventional technique, it also significantly decreases both the incidence and severity of nasopharyngeal trauma, as well as the need for the use of Magill forceps.     

Use of the ProSeal laryngeal mask airway for pressure-controlled ventilation with and without positive end-expiratory pressure in paediatric patients: a randomized, controlled study

Background. Tracheal intubation and positive end-expiratorypressure (PEEP) are frequently used in children to avoid airwayclosure and atelectasis during general anaesthesia. Also, thelaryngeal mask airway (LMA     

The effects of tracheal tube cuffs filled with air,saline or alkalinised lidocaine on haemodynamic changes and laryngotracheal morbidity in children: a randomised,controlled trial

We studied the effects of tracheal tube cuffs filled with air, saline or alkalinised lidocaine on haemodynamic changes during tracheal extubation and postoperative laryngotracheal morbidity in children. We randomly allocated 164 children aged 3–13 years undergoing general anaesthesia to one of four groups; tracheal tube cuffs filled with air (n = 41); saline (n = 41); alkalinised lidocaine 0.5% (n = 41); or alkalinised lidocaine 1% (n = 41). Intracuff pressure was monitored and maintained below 20 cmH₂O. The mean (SD ) increases in systolic blood pressure after tracheal extubation compared with before extubation were 10.9 (10.8) mmHg, 7.3 (17.7) mmHg, 4.1 (10.5) mmHg and 1.9 (9.5) mmHg in the air, saline, 0.5% and 1% alkalinised lidocaine groups, respectively (p = 0.021). The mean (SD ) increases in diastolic blood pressure after tracheal extubation compared with before extubation were 3.9 (9.7) mmHg, 7.9 (14.6) mmHg, 0.7 (10.4) mmHg and 3.6 (6.9) mmHg in the air, saline, 0.5% and 1% alkalinised lidocaine groups, respectively (p = 0.019). The mean (SD ) increases in heart rate after tracheal extubation compared with before extubation were 14.2 (7.6) beats.min^?1, 15.5 (13.1) beats.min^?1, 5.2 (9.6) beats.min^?1 and 4.1 (6.6) beats.min^?1 in the air, saline, 0.5% and 1% alkalinised lidocaine groups, respectively (p < 0.001). The incidence of sore throat 8 h after tracheal extubation was 22.0% in the air‐filled group, 9.8% in the saline group, 4.9% in the 0.5% alkalinised lidocaine group and 2.4% in the 1% alkalinised lidocaine group, p = 0.015. We conclude that filling the tracheal tube cuff with alkalinised lidocaine‐filled reduces the haemodynamic response to tracheal extubation and postoperative laryngotracheal morbidity in children.     

Cognitive outcomes at ages seven and nine years in South African children from the children with HIV early antiretroviral (CHER) trial: a longitudinal investigation

IntroductionMany children living with HIV (CLWH) display impaired cognition. Although early combination antiretroviral therapy (ART) produces improved cognitive outcomes, more long‐term outcome data are needed. After concluding the Children with HIV Early antiRetroviral (CHER) trial in 2011, we investigated cognitive performance, at seven and nine years of age. Participants had been randomized to deferred ART (ART‐Def; n = 22); immediate time‐limited ART for 40 weeks (ART‐40W; n = 30) and immediate time‐limited ART for 96 weeks (ART‐96W; n = 18). We also recruited HIV‐exposed uninfected (CHEU; n = 28) and HIV‐unexposed (CHU; n = 35) children.MethodsData were collected between May 2012 and December 2017. Mixed‐model repeated‐measures ANOVAs assessed differences over time between CLWH (ART‐40W, ART‐96W and ART‐Def) and CHIV‐ CHEU and CHU between ART‐Early (ART‐40W and ART‐96W), ART‐Def, CHEU and CHU; and between ART‐40W, ART‐96W, ART‐Def, CHEU and CHU.ResultsAll comparisons found significant effects of Time for most outcome variables (better scores at nine than at seven years; ps < 0.05). The first ANOVAs found that for (a) motor dexterity, CLWH performed worse than CHIV‐ at seven years (p < 0.001) but improved to equivalence at nine years, (b) visual‐spatial processing and problem solving, only CLWH (p < 0.04) showed significant performance improvement over time and (c) working memory and executive function, CLWH performed worse than CHIV‐ at both seven and nine years (p = 0.03 and 0.04). The second ANOVAs found that for (a) working memory, CHU performed better than ART‐Early and CHEU (p < 0.01 and <0.04), and (b) motor dexterity, ART‐Def performed worse than ART‐Early, CHEU and CHU at seven years (p = 0.02, <0.001 and <0.001 respectively) but improved to equivalence at nine years (ps > 0.17). Similarly, for motor dexterity, ART‐Def performed worse than ART‐96W, CHEU and CHU at seven years (p < 0.04, <0.001 and <0.001) but improved to equivalence at nine years (ps > 0.20).ConclusionsAlthough neurocognitive developmental trajectories for treatment groups and controls were largely similar (i.e. performance improvements from 7 to 9), all ART‐treated children, regardless of treatment arm, remain at risk for cognitive deficits over early school ages. Although the nature of these deficits may change as cognitive development proceeds, there are potential negative consequences for these children’s future learning, reasoning and adaptive functioning.     

The effect of different types of insoles or shoe modifications on medial loading of the knee in persons with medial knee osteoarthritis: a randomised trial

Many conservative treatments exist for medial knee osteoarthritis (OA) which aims to reduce the external knee adduction moment (EKAM). The objective of this study was to determine the difference between different shoes and lateral wedge insoles on EKAM, knee adduction angular impulse (KAAI), external knee flexion moment, pain, and comfort when walking in individuals with medial knee OA. Seventy individuals with medial knee OA underwent three‐dimensional walking gait analysis in five conditions (barefoot, control shoe, typical wedge, supported wedge, and mobility shoe) with pain and comfort recorded concurrently. The change in EKAM, KAAI, external knee flexion moment, pain, and comfort were assessed using multiple linear regressions and pairwise comparisons. Compared with the control shoe, lateral wedge insoles and barefoot walking significantly reduced early stance EKAM and KAAI. The mobility shoe showed no effect. A significant reduction in latter stance EKAM was seen in the lateral wedge insoles compared to the other conditions, with only the barefoot condition reducing the external knee flexion moment. However, the mobility shoe showed significant immediate knee pain reduction and improved comfort scores. Different lateral wedge insoles show comparable reductions in medial knee loading and in our study, the mobility shoe did not affect medial loading. © 2015 The Authors. Journal of Orthopaedic Research Published by Wiley Periodicals, Inc. J Orthop Res 33:1646–1654, 2015.     

Evaluating the effectiveness of a self‐management exercise intervention on wound healing,functional ability and health‐related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial

Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence‐based care on the healing rates, functional ability and health‐related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12‐week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health‐related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention‐to‐treat) analysis to highlight the importance of adherence to an exercise intervention. Intention‐to‐treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health‐related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health‐related quality of life), intention‐to‐treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self‐management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.