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Does Prewarming the I-Gel Supraglottic Airway Device Fit the Larynx Better Compared to Keeping It at Room Temperature for Non-Pa

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Does Prewarming the I-Gel Supraglottic Airway Device Fit the Larynx Better Compared to Keeping It at Room Temperature for Non-Pa Open Access Research BMJ Open: first published as 10.1136/bmjopen-2014-006653 on 13 January 2015. Downloaded from Does prewarming the i-gel supraglottic airway device fit the larynx better compared to keeping it at room temperature for non-paralysed, sedated patients: a randomised controlled trial Nobuyasu Komasawa,1 Isao Nishihara,2 Shinichi Tatsumi,1 Toshiaki Minami1 To cite: Komasawa N, ABSTRACT et al Strengths and limitations of this study Nishihara I, Tatsumi S, . Objective: This study aimed to test the hypothesis Does prewarming the i-gel that the i-gel supraglottic airway device would fit the ▪ supraglottic airway device fit A previous study revealed that prewarming the larynx and provide better sealing pressure if the larynx better compared to supraglottic device i-gel to 42°C facilitated the keeping it at room prewarmed to 42°C relative to the device kept at room insertion efficacy under muscle relaxation in anaes- temperature for non- temperature in non-paralysed, sedated patients. thetised, paralysed patients. However, the utility of paralysed, sedated patients: Methods: A total of 74 adult patients were assigned prewarming of i-gel for patients in non-paralysed, a randomised controlled trial. to the warm (i-gel prewarmed to 42°C; W group; 37 sedated patients has not been validated as yet. BMJ Open 2015;5:e006653. patients) or the control (i-gel kept at room temperature; ▪ Prewarming of the i-gel did not facilitate insertion doi:10.1136/bmjopen-2014- C group; 37 patients) groups. Anaesthesia was induced efficacy such as insertion success rate or sealing 006653 with propofol and fentanyl. The i-gel was prewarmed to pressure in non-paralysed, sedated patients. 42°C for 30 min before insertion in the W group, but ▪ Our result suggests that we can keep the i-gel at ▸ Prepublication history for kept at room temperature (approximately 23°C) for the room temperature for emergent airway manage- this paper is available online. C group. The number of attempts made until ment in non-paralysed patients. To view these files please successful insertion and sealing pressure were ▪ Our randomised prospective study is performed visit the journal online compared between the two groups. only in one hospital, large-scale study may be (http://dx.doi.org/10.1136/ Results: Insertion was successful with one attempt in http://bmjopen.bmj.com/ bmjopen-2014-006653). needed in the future. 35 cases each for the W and C groups. Two attempts Received 16 September 2014 were needed in two cases for the W group and one Revised 26 December 2014 case for the C group. There was one failed attempt in Accepted 29 December 2014 the C group, but none in the W group. None of the The i-gel is composed of a thermoplastic fi differences between the two groups were significant elastomer which is suggested to t the laryn- (p=0.51). Sealing pressure was slightly, but not geal structure by body temperature expos- significantly, higher in the W group than in the ure.3 However, a previous study in which i-gel C group (W group 22.6±6.1 cm H2O; C group 20.7 was prewarmed to 37°C did not demonstrate ±6.1 cm H2O; p=0.15). any significant difference in sealing pres- on September 28, 2021 by guest. Protected copyright. Conclusions: Prewarming of the i-gel to 42°C did not sure.4 We considered that i-gel prewarmed to increase the success rate of insertion, nor did it 37°C may be cooled during the insertion significantly increase sealing pressure in anaesthetised, process and that insertion and higher pre- non-paralysed patients. Our data suggest that we can warming temperature could help the cuff keep the i-gel at room temperature for emergency airway exert a higher sealing pressure. We previ- management for non-paralysed, sedated patients. ously reported significant differences in Trial registration number: University Medical Information Network, Japan 000012287. sealing pressure when the i-gel was pre- 1Department of warmed to 42°C under muscle relaxation.5 Anaesthesiology, Osaka As i-gel is used not only under muscle relax- Medical College, Takatsuki, Osaka, Japan ant contexts but also without muscle relaxation 2Department of INTRODUCTION in non-paralysed, sedated or cardiopulmonary Anaesthesiology, Hokusetsu The supraglottic airway device, i-gel (i-gel: suppressed patients, we hypothesised that General Hospital, Takatsuki, Intersurgical, Wokingham, UK), is a single- evaluating the prewarming effect in non- Osaka, Japan use supraglottic device (SGD) with a gel-like paralysed patients preserving spontaneous ven- Correspondence to cuff and reported to be useful for airway tilation would be informative. Dr Nobuyasu Komasawa; management under general anaesthesia or Accordingly, the present study was per- [email protected] during resuscitation.12 formed to investigate this hypothesis by Komasawa N, et al. BMJ Open 2015;5:e006653. doi:10.1136/bmjopen-2014-006653 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-006653 on 13 January 2015. Downloaded from comparing airway-sealing pressure between i-gel devices nitrous oxide in oxygen in order to maintain spontan- prewarmed to 42°C and those kept at room temperature eous ventilation. Patients were extubated postoperatively, (approximately 23°C) in non-paralysed, sedated patients. and hoarseness and pharyngeal pain after arousal were assessed by non-blinded anaesthesiologists. Statistical analysis was performed with JMP 11 (SAS METHODS Institute Inc, Cary, North Carolina, USA). The χ2 test From November 2013 to February 2014, 74 patients and Mann-Whitney U test were used for data pertaining aged 20–85 years who were to undergo general anaesthe- to patient characteristics. The χ2 test was used for the sia (maintaining spontaneous ventilation) in the supine number of insertion attempts and hoarseness and pha- position were assigned at random by using the envelope ryngeal pain incidents. The Mann-Whitney U test was method to one of the two groups: i-gel prewarmed to used to compare sealing pressure. Data are presented as 42°C (W group; 37 patients) and i-gel kept at room tem- mean±SD with 95% CIs. p Value <0.05 was considered perature (C group; 37 patients). Exclusion criteria statistically significant. included difficult airway such as mouth opening With respect to sample size, the incidence of success- fi restriction and any contraindication for the use of SGDs ful i-gel insertions (sealing pressure >15 cm H2Oon rst (eg, morbid obesity (body mass index, >35), gastro- insertion) in a non-warming preliminary trial in the pre- oesophageal reflux and previous upper abdominal vious study with muscle relaxation was approximately surgery) or a recent history (within 7 days) of upper 50%. As such, we hypothesised that prewarming i-gel respiratory tract infection.4 would increase the successful insertion rate to 80%.5 To Routine monitoring of blood pressure, heart rate, detect this difference with 80% power at a 5% signifi- ECG, percutaneous oxygen saturation and end-tidal cance level, 36 patients would be necessary in each carbon dioxide tension was performed. Without any group. Therefore, we planned to recruit 37 patients for premedication, propofol 1–2 mg/kg and fentanyl 1.0– each group to adjust for missing data. 2.0 μg/g were administered to patients. Doses of seda- tives and analgesics were limited so as to maintain RESULTS spontaneous ventilation to a certain extent. In case of Patient characteristics are shown in table 1. None of the loss of respiratory arrest, the anaesthesiologist per- following parameters differed significantly between the formed mask ventilation until the recovery of spontan- W and C groups: age, sex, body weight, height, body eous ventilation. The i-gel was warmed to 42°C in a mass index, duration of surgery, duration of anaesthesia, heating cabinet with an automatic temperature control Mallampati score and i-gel size used. for 30 min before use in the W group. The time from i-gel delivery from the heating cabinet to insertion into Number of attempts to successful insertion and sealing the mouth is approximately 30–60 s. The approximate http://bmjopen.bmj.com/ pressure temperature of the i-gel was 37–39°C at the time of The number of insertion attempts was one for 35 cases insertion, which was measured in the preliminary study. and two for 2 cases in the W group, and one for 35 On the basis of this preliminary study, we decided the cases and two for 1 case in the C group. There was also prewarming to 42°C.5 For the C group, i-gel was stored one failure case in the C group. The number of success- at room temperature (approximately 23°C). A thermom- ful ventilations in the first trial did not significantly eter was used to measure the temperature of the heating differ between the W and C groups (p=0.51). After suc- cabinet directly. The decision of whether to use a size 3 cessful insertion, the sealing pressure was slightly, but on September 28, 2021 by guest. Protected copyright. or 4 i-gel was based on the patient’s body weight, as per not significantly, higher in the W group than in the the manufacturer’s instructions. The anaesthesiologist C group (W group 22.6±6.1 cm H O; C group made size determinations for patients weighing 50–60 kg 2 20.7±6.1 cm H O; p=0.15; table 2). (ie, between sizes 3 and 4). Sealing pressure was mea- 2 sured after insertion of i-gel with the indicator attached Incidence of hoarseness and pharyngeal pain after to the anaesthesia machine. Successful insertion was general anaesthesia confirmed by bilateral chest wall movement, auscultation Hoarseness was not seen in either group.
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