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Completed

NCT Number: NCT03365557

Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airway peak pressure

Procedure

Air was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.

Primary outcomes

  1. The intracuff gas volume before pneumoperitoneum

    Time frame: Intraoperative

    The changes of intracuff gas volume before pneumoperitoneum

  2. The intracuff gas volume after pneumoperitoneum

    Time frame: Intraoperative

    The changes of intracuff gas volume after pneumoperitoneum

  3. The intracuff pressure before pneumoperitoneum

    Time frame: Intraoperative

    The changes of intracuff pressure before pneumoperitoneum

  4. The intracuff pressure after pneumoperitoneum

    Time frame: Intraoperative

    The changes of intracuff pressure after pneumoperitoneum

Secondary outcomes

  1. Throat complications

    Time frame: From the end of operation till 24 hs postoperative

    Throat pain, swallow discomfort and hematoma

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 7, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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