Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

Not Applicable

Completed

• Conditions: Laryngeal Mask Airway
• Interventions: Procedure: Airway peak pressure

• Registration Number: NCT03365557
• Lead Sponsor: Yangzhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-03-31
• Study First Submitted: 2017-11-10
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Completion: 2018-04-30
• Last Update Submitted: 2020-03-15
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria

• Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracuff pressure set by airway peak pressure	Airway peak pressure	-
Intracuff pressure set at 60 mmHg	Airway peak pressure	-

Primary Outcome Measures

Name	Time	Method
The intracuff gas volume after pneumoperitoneum	Intraoperative	The changes of intracuff gas volume after pneumoperitoneum
The intracuff gas volume before pneumoperitoneum	Intraoperative	The changes of intracuff gas volume before pneumoperitoneum
The intracuff pressure before pneumoperitoneum	Intraoperative	The changes of intracuff pressure before pneumoperitoneum
The intracuff pressure after pneumoperitoneum	Intraoperative	The changes of intracuff pressure after pneumoperitoneum

Secondary Outcome Measures

Name	Time	Method
Throat complications	From the end of operation till 24 hs postoperative	Throat pain, swallow discomfort and hematoma