Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

Laryngeal Mask Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365557
• Other study ID #: 20171110
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: December 2017
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2018
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Mask Airway

Intervention

Procedure:
• Airway peak pressure
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intracuff gas volume before pneumoperitoneum	The changes of intracuff gas volume before pneumoperitoneum	Intraoperative
Primary	The intracuff gas volume after pneumoperitoneum	The changes of intracuff gas volume after pneumoperitoneum	Intraoperative
Primary	The intracuff pressure before pneumoperitoneum	The changes of intracuff pressure before pneumoperitoneum	Intraoperative
Primary	The intracuff pressure after pneumoperitoneum	The changes of intracuff pressure after pneumoperitoneum	Intraoperative
Secondary	Throat complications	Throat pain, swallow discomfort and hematoma	From the end of operation till 24 hs postoperative