Comparison of oropharyngeal leak pressure between the Ambu® AuraGain™ and the LMA® Supreme™ supraglottic airways: a randomized-controlled trial

Purpose

Studies comparing the recently introduced Ambu® AuraGain? (Auragain) with the LMA® Supreme? (Supreme) supraglottic airway (SGA) have reported conflicting results regarding differences in oropharyngeal leak pressure (OLP). This randomized-controlled trial investigated the OLP of the Auragain compared with the Supreme in patients undergoing ambulatory surgery.

Methods

Adult patients with a body mass index ≤ 40 kg·m^?2 presenting for ambulatory surgery and requiring an SGA were randomized to receive either the Auragain or the Supreme. Anesthesia was induced with lidocaine (1 mg·kg^?1), fentanyl (1-2 μg·kg^?1), and propofol (2-3 mg·kg^?1). The SGA was inserted using a standard technique with the cuff inflated to 60 cmH₂O. The groups were compared for the primary outcome of OLP.

Results

One hundred sixty-five patients (n = 81, Auragain; n = 84, Supreme) completed the study. Demographics were similar between the groups. The mean (standard deviation [SD]) OLP was significantly higher in the Auragain than in the Supreme group [26.4 (2.8) cmH₂O vs 21.6 (3.4) cmH₂O, respectively; difference in means (MD), 4.8 cmH₂O; 95% confidence interval (CI), 3.9 to 5.8; P < 0.001]. The mean (SD) insertion time was longer in the Auragain than in the Supreme group [13 (4) sec vs 11 (3) sec, respectively; MD, 2 sec; 95% CI, 1 to 3 sec; P < 0.001].

Conclusion

In patients undergoing ambulatory anesthesia, the OLP was higher but took longer to insert with the Auragain than with the Supreme. A higher OLP may allow for SGAs to be utilized in a wider range of patients and procedures.

Trial registration

www.clinicaltrials.gov (NCT02816463). Registered 28 June 2016.

     

Diet or dialysis in the elderly? The DODE study: a prospective randomized multicenter trial

There are no solid data on the real advantage of an early start of dialysis, as suggested by the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we cannot distinguish between the detrimental effect on nutrition of too low a residual renal function or too long a period of low protein-diet, per se. However, it appears that a very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the start of dialysis and can slow the progression of chronic renal failure. EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate becomes higher after the start of dialysis compared to the pre-dialysis period. Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer elderly patients better survival and better quality of life than dialysis? The answer can only come from a prospective, randomized trial, in elderly patients, starting at the GFR values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids, and with dialysis.     

Comparison of the Truview PCD™ and the GlideScope® video laryngoscopes with direct laryngoscopy in pediatric patients: a randomized trial

Introduction

The GlideScope^® video laryngoscope has a 60° angled blade and the blade of the Truview PCD? video laryngoscope has an optical lens that provides a 46° refraction of the viewing angle. Despite successful results using the GlideScope in adults, few studies have been published regarding its use in pediatric patients. We therefore tested our joint primary hypothesis that the GlideScope and the Truview PCD video laryngoscopes provide superior visualization to direct laryngoscopy and are non-inferior regarding time to intubation.

Methods

One hundred thirty-four patients (neonate to ten years of age, American Society of Anesthesiologists physical status I-III) scheduled for general surgical procedures were randomized to tracheal intubation using the Truview PCD or GlideScope video laryngoscope or direct laryngoscopy (Macintosh blade). The laryngoscopic view was scored using the Cormack-Lehane scale. Time to intubation (defined as the time from the moment the device entered the patient’s mouth until end-tidal CO₂ was detected) and the number of attempts were recorded.

Results

The Cormack-Lehane views attained using the GlideScope (P > 0.99) and Truview PCD (P = 0.18) were not superior to the views attained with direct laryngoscopy. Furthermore, the view attained using the GlideScope was significantly worse than that attained using direct laryngoscopy (P < 0.001). Fewer patients showed Cormack-Lehane grade I views with the GlideScope than with the Truview PCD (14% vs 82%, respectively; 95% confidence interval [CI] ?91% to ?46%). The observed median [Q1, Q3] times to intubation were: 39 [31, 59] sec, 44 [28, 62] sec, and 23 [21, 28] sec with the GlideScope, Truview PCD, and direct laryngoscopy, respectively, with median differences of 14 sec (95% CI 7 to 26, GlideScope – direct laryngoscopy) and 17 sec (95% CI 6 to 28, Truview PCD – direct laryngoscopy).

Conclusion

The Cormack-Lehane views attained using the GlideScope and the Truview PCD video laryngoscopes were not superior to views attained using direct laryngoscopy. Visualization with the GlideScope was significantly worse than with direct laryngoscopy. Use of the GlideScope and Truview PCD systems should be restricted to patients with specific indications.     

Controlling intraoperative hemorrhage during burn surgery: A prospective,randomized trial comparing NuStat® hemostatic dressing to the historic standard of care

Introduction

One of the primary intraoperative challenges during burn surgery is to adequately excise the burn while avoiding massive hemorrhage. This has become increasingly important, as we see more burn patients that are older and with more medical comorbidities. While adequate excision down to healthy tissues for deep burns is essential for skin graft to take, it also leads to active bleeding that can be a challenge to control. Good hemostasis is imperative as a hematoma is the most common cause of graft loss. Several new products have become available to help control intraoperative hemorrhage. A new hemostatic dressing, NuStat^®, is available and approved by FDA in United States.

Harmonic Focus™ versus “knot tying” during total thyroidectomy: a randomized trial

The objective of the study is to compare the outcome of total thyroidectomy (TT) using the Harmonic Focus? (HF) versus conventional “knot tying” (KT) in terms of operative time, parathyroid function and post-operative complications. This prospective study was designed with a random allocation of subjects using a drawing technique. Eighty-one consecutive patients were submitted to TT in 2010 and randomly divided into two groups: 43 patients operated using HF (HF group) and 38 patients operated using KT (KT group). Parathyroid function was evaluated by parathyroid hormone (PTH) level at 1 h postoperatively and calcium level at first post-operative day. Indications for medical therapy were PTH < 15 pg/ml and/or calcium < 8.0 mg/dl and/or clinical signs or symptoms of hypocalcemia. Main outcomes were operative time, PTH and calcium levels, need for medical therapy and post-operative complications. Mean operative time was significantly lower in HF group compared with KT group (100 ± 34 vs. 119 ± 30 min). There were no significant differences concerning transient hypoparathyroidism requiring calcium and/or vitamin D therapy: 17 patients (39.5%) in HF group versus 21 (55.3%) in KT group. Five patients (11.6%) in HF group experienced symptomatic hypocalcemia versus 6 (15.8%) in KT group, without statistically significant difference. No patients experienced recurrent nerve injury. HF is a new ergonomic, reliable device developed for thyroid surgery. According to our results, HF is a safe, time-saving alternative to “knot tying” thyroidectomy, with no influence on parathyroid function, medical therapy and nerve injury.     

Early results of a single-blinded,randomized, controlled,Internet-based multicenter trial comparing Prolene and Vypro II mesh in Lichtenstein hernioplasty

Background: The standard polypropylene mesh used in Lichtensteins operation induces a strong foreign-tissue reaction with potentially harmful effects. A mesh with less polypropylene could possibly be beneficial. Patients and methods: Six hundred men with inguinal hernias were randomized to Lichtensteins operation with Prolene or Vypro II in a single-blinded multicenter trial. The randomization was performed by a computer algorithm in a database through the Internet. All data were entered and directly validated in the database through the Internet. Results The meshes had comparable results in return to work, return to daily activities, complications, postoperative pain, and quality of life during the first 8 weeks of rehabilitation. Conclusions Lichtensteins operation with either Prolene or Vypro II is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery. The study was facilitated by the use of a database through the Internet.     

Bupivacaine use in the Insuflow® device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial

Background

Recent evidence [Surg Endosc (2007) 21: 602–606] demonstrates that intraperitoneal bupivacaine administered as an aerosol via a special catheter is safe and significantly decreases postoperative pain in laparoscopic surgery. We currently use the Insuflow^® device (Lexion Medical) routinely to warm and humidify gas in laparoscopic surgery. The purpose of this study is to determine whether using bupivacaine instead of water in existing technology already in use (Insuflow) will result in decreased postoperative pain, without increasing operative time or cost.

Methods

Using a double-blind methodology, 50 patients undergoing elective outpatient laparoscopic cholecystectomy were randomized to a study drug: either 10 ml of 0.5% bupivacaine (50 mg) or 10 ml of sterile water. The study drug was injected into the Insuflow in the standard fashion and the operation commenced routinely. No perioperative nonsteroidal anti-inflammatory drugs were used. Using a standard 0–10 pain-scoring scale, patients were assessed by perioperative nurses at 1 and 2 h postoperatively. Pain was again assessed at 24 h by telephone interview, along with the number of narcotic oral analgesics used in the first 24 h.

Results

Fifty patients were randomized, 25 in each group; the groups were comparable. All patients completed the study and 100% follow-up was obtained. All patients were discharged the same day and there were no significant complications in either group, and specifically no complications attributed to bupivacaine or use of the Insuflow device. There were no differences in pain at 1 and 2 h. There was less pain in the bupivacaine group at 24 h, but this was not statistically significant (P = 0.055).

Conclusions

Bupivacaine use in the Insuflow device is safe. No significant differences in postoperative pain were noted in this study compared to using water.     

Management of intraoperative hemorrhage during NOTES®: a prospective, randomized comparison

Background

The optimal strategy to manage intraoperative hemorrhage during NOTES^® is unknown. A randomized comparison of three instruments for hemorrhage control was performed [prototype endoscopic bipolar hemostasis forceps (BELA) vs. prototype endoscopic clip (E-CLIP) applier versus laparoscopic clip (L-CLIP) applier].

Methods

A hybrid transvaginal NOTES model in swine was used, with hemorrhage induced in either the gastroepiploic (GE) arteriovenous bundle (vessel diameter ~3 mm) or in distal mesenteric vessels (vessel diameter ~1–2 mm). Hemostasis was attempted three times per vessel using each instrument in a randomized order. Full laparoscopic salvage was performed if hemorrhage persisted beyond 10 min. Outcomes included primary success rate (PS), primary hemostasis time (PHT), number of device applications (DA), and overall hemostasis time (OHT, including salvage).

Results

Seventy hemostasis attempts were made in 12 swine. PS was 42–67 % for the GE vessels, with no difference between instruments. PHT and OHT also were similar between instruments, with the BELA and L-CLIP having a higher number of DA. PS was (80–100 %) in mesenteric vessels, with the BELA and L-CLIP resulting in a shorter mean PHT compared with the E-CLIP.

Conclusions

All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1–2 mm) in a porcine model is effective using all three instruments but may be most efficient with the BELA or L-CLIP. Large vessel bleeding (≥3 mm) may be best managed by adding laparoscopic ports for assistance while maintaining a low threshold for conversion to full laparoscopy.     

The Flex-Tip™ tracheal tube does not reduce the incidence of postoperative sore throat: a randomized controlled trial

Purpose

Sore throat after tracheal intubation is common with an incidence of 30-70%. The Parker Flex-Tip? endotracheal tube (ETT) is designed to reduce trauma during ETT placement. This randomized single-blinded trial was designed to assess whether using the Flex-Tip ETT would reduce the incidence of postoperative sore throat and/or vocal change.

Methods

A Flex-Tip or a Mallinckrodt Hi–Lo® cuffed ETT was used by random allocation in 200 patients with normal-appearing airways requiring elective orotracheal intubation. On the second postoperative day, a blinded assessor recorded the incidence and severity of postoperative sore throat and voice alteration. The primary outcome was the incidence of moderate or severe sore throat. Secondary outcomes included vocal change, time to intubation, number of attempts/failures, incidence of oropharyngeal bleeding, and subjective ease of intubation.

Results

Demographic data were similar between the two groups. Moderate or severe sore throat was observed in 12% of patients with the Flex-Tip ETT and 6% of patients with the Mallinckrodt Hi–Lo ETT (odds ratio [OR] 2.1; 95% confidence intervals [CI] 0.70 to 7.1; P = 0.14). The incidence of moderate or severe vocal change was 6% and 3%, respectively (OR 2.0; 95% CI 0.42 to 12.9; P = 0.50). Time to intubation, number of intubation attempts, incidence of oropharyngeal bleeding, and ease of intubation did not differ significantly between groups.

Conclusion

In this study involving experienced clinicians, no significant difference was observed in the incidence of postoperative sore throat or vocal change between the Flex-Tip ETT and the standard Mallinckrodt Hi-Lo cuffed ETT. This trial was registered at www.clinicaltrials.gov, NCT01095861.     

Nasotracheal fibreoptic intubation: a randomised controlled trial comparing the GlideRite® (Parker-Flex® Tip) nasal tracheal tube with a standard pre-rotated nasal RAE™ tracheal tube

In a randomised controlled study, we compared the ease of railroading a GlideRite^® nasal tracheal tube over a fibrescope with that of a pre‐rotated RAE? nasal tracheal tube. We studied 110 anaesthetised patients with no known airway difficulties undergoing elective dental or maxillofacial surgery. Impingement was more common with the GlideRite tubes (11/55 (20%)) compared with the pre‐rotated RAE tubes (3/55 (5%); p = 0.02). The median (IQR [range]) time to intubation (GlideRite 7.6 (4.7–10.8 [3.0–46.2]) s; RAE 8.0 (6.2–10.7 [2.4–30.0]) s) and postoperative sore throat numerical ratings (GlideRite 2 (0–3 [0–10]); RAE 2 (0–5 [0–8])) were similar. A 90° anticlockwise pre‐rotation of a standard nasal RAE tube has a higher initial rate of successful railroading at first attempt and is therefore superior to a GlideRite nasotracheal tube during nasal fibreoptic intubation.     

Ambu® Aura Gain™ versus Ambu® Aura Once™ in children: a randomized,crossover study assessing oropharyngeal leak pressure and fibreoptic position

Canadian Journal of Anesthesia/Journal canadien d'anesthésie - The Ambu® Aura Gain™ is a new second-generation supraglottic airway device that—because of a wider curvature...     

The LMA® ProtectorTM in anaesthetised,non-paralysed patients: a multicentre prospective observational study

We evaluated the LMA ^® Protector^TM in 280 ASA physical status 1–3 patients aged 18–75 years by assessing the ease of insertion, insertion time, oropharyngeal leak pressure, ease of gastric tube passage and complications. First-attempt and overall insertion success was 234/280 (84; 95%CI 79–88%) and 274/280 (98; 95–99%). Median (IQR [range]) insertion time was 17 (12–25 [5–44]) s, and manoeuvres to facilitate insertion were required in 56 (50–63)% of patients. Median oropharyngeal leak pressure was 31 (26–36 [14–40]) cmH₂O. Multivariate analysis identified two risk factors for oropharyngeal leak pressure < 25 cmH₂O: male sex (OR 2.44; 1.01–5.91, p = 0.048) and the insertion of a LMA size different to that recommended by weight (OR 1.98; 0.97–4.03, p = 0.06). Gastric tube insertion was possible in 256 out of 274 patients (93%). On fibreoptic view, vocal cords were visible in 86% of patients. During maintenance, 14 patients (5%) required airway manipulation. There were no episodes of regurgitation or aspiration. Blood staining on LMA removal was present in 70 out of 280 patients (25%). Use of the LMA Protector appears safe and is associated with a high success rate, provision of a highly effective seal and low rates of clinical complications. These attributes would suggest considerable potential for use during anaesthesia.     

The LMA CTrach™ in morbidly obese and lean patients undergoing gynecological procedures: a comparative study

Purpose

The tracheas of obese patients may be more difficult to intubate than those of normal-weight patients. The aim of this study was to compare the airway management quality in morbidly obese and lean patients with use of the LMA CTrach.

Methods

After Ethics Committee approval, 60 adult patients (30 morbidly obese patients with body mass index >40 kg/m² and 30 lean patients with body mass index <30 kg/m²) scheduled to undergo gynecological surgery were enrolled in this prospective study. The induction of anesthesia was standardized using propofol, fentanyl, and rocuronium. Ventilation and intubation success rates, time taken to achieve successful ventilation, and intubation through the CTrach and airway complications were recorded.

Results

The CTrach was successfully inserted and adequate ventilation through the CTrach was achieved in 59 patients (98%). Only 1 patient in the lean group was not able to ventilate through the CTrach. We were successful in endotracheal intubation, either under vision or blind, in 56 patients (93%). We were able to view the larynx in 51 patients (85%). Total intubation time was significantly longer in morbidly obese patients, 69 (311) s, than in lean patients, 33 (107) s [median (range)] (P < 0.001).

Conclusions

We concluded that the time to intubate the trachea in obese patients was significantly longer than in lean patients when the LMA CTrach was used.     

Efficacy of a new dual channel laryngeal mask airway,the LMA®Gastro™ Airway,for upper gastrointestinal endoscopy: a prospective observational study

Background

Significant cardiorespiratory events are frequent in patients undergoing gastrointestinal endoscopy. Central to the occurrence of respiratory events is an unsecured airway. This study sought to determine the efficacy of a new laryngeal mask airway, the LMA^®Gastro^TM Airway (Teleflex Medical, Athlone, Ireland), in patients undergoing upper gastrointestinal endoscopy. New design features include a dedicated channel for oesophageal intubation and separate channel with terminal cuff for lung ventilation.

A randomised, controlled trial comparing the Airtraq™ optical laryngoscope with conventional laryngoscopy in infants and children

The Airtraq^? optical laryngoscope became available in paediatric sizes in the UK in May 2008. We conducted a randomised, controlled trial comparing the Airtraq with conventional laryngoscopy during routine anaesthesia in children. We hypothesised that the Airtraq laryngoscope would perform as well as conventional laryngoscopy. Sixty patients (20 infants and 40 children) were recruited. The mean (SD) intubation time using the Airtraq was longer than conventional laryngoscopy overall (47.3 (32.6) vs 26.3 (11.5) s; p = 0.002), though the difference was only significant for children (p = 0.003) and not for infants (p = 0.29). The Airtraq provided a better view of the larynx compared with conventional laryngoscopy (in infants (percentage of glottic opening scores 100 (95–100 [90–100]) vs 77 (50–90 [40–100]), respectively; p = 0.001; visual analogue scores for field of view 9.2 (9.2–9.5 [8.2–10.0]) vs 6.8 (5.1–8.0 [4.7–10.0]), respectively; p = 0.001). In children, the Airtraq provided a similar view of the larynx (percentage of glottic opening scores 100 (100–100 [40–100]) vs 100 (90–100 [50–100]), respectively; visual analogue scores for field of view 9.2 (8.6–10.0 [7.0–10.0]) vs 9.2 (8.6–10.0 [5.6–10.0]), respectively; both p > 0.05), compared with conventional laryngoscopy.