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Clinical Trials/NCT03365557
NCT03365557
Completed
Not Applicable

A Clinical Study of the Setting of Laryngeal Mask Airway Intracuff Pressure Based on Airway Peak Pressure

Yangzhou University0 sites120 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laryngeal Mask Airway
Sponsor
Yangzhou University
Enrollment
120
Primary Endpoint
The intracuff gas volume after pneumoperitoneum
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
April 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Zhang

Principal Investigator

Yangzhou University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The intracuff gas volume after pneumoperitoneum

Time Frame: Intraoperative

The changes of intracuff gas volume after pneumoperitoneum

The intracuff gas volume before pneumoperitoneum

Time Frame: Intraoperative

The changes of intracuff gas volume before pneumoperitoneum

The intracuff pressure before pneumoperitoneum

Time Frame: Intraoperative

The changes of intracuff pressure before pneumoperitoneum

The intracuff pressure after pneumoperitoneum

Time Frame: Intraoperative

The changes of intracuff pressure after pneumoperitoneum

Secondary Outcomes

  • Throat complications(From the end of operation till 24 hs postoperative)

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