NCT03365557

Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

Completed NA Last updated 18 March 2020

What this trial tests

NA trial testing Airway peak pressure in Laryngeal Mask Airway in 120 participants. Completed in 30 April 2018.

Timeline

1 October 2016

Primary endpoint
31 March 2017

30 April 2018

Quick facts

Lead sponsor	Yangzhou University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	120
Start date	1 October 2016
Primary completion	31 March 2017
Estimated completion	30 April 2018

Drugs / interventions tested

• Airway peak pressure

Conditions studied

• Laryngeal Mask Airway — all drugs for Laryngeal Mask Airway →

Sponsor

Yangzhou University

Who can join

Adults 18 to 65, any sex, with Laryngeal Mask Airway. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as \[(VTI-VTE)/ VTI×100%\]. Throat complications of all the patients in 24 hours after surgeries were also recorded.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Peak Inspiratory Pressure-Guided Setting of Intracuff Pressure for Laryngeal Mask Airway Supreme™ Use during Laparoscopic Cholecystectomy: A Randomized Controlled Trial.
   Wang MH, Zhang DS, Zhou W, Tian SP, et al · · 2021 · cited 6× · PMID 32354298 · DOI 10.1080/08941939.2020.1761487