Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

December 12, 2018 updated by: Junyong In, MD, PhD, DongGuk University
The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 10326
        • Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I, II
  • Body mass index < 30 kg/m2
  • Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position

Exclusion Criteria:

  • History of airway-related or pulmonary diseases/abnormalities
  • When difficult intubation is anticipated
  • History of general anesthesia within the past 3 months
  • Pregnancy
  • History of smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cuff sealing by MOVT
MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured.
Procedure: MOVT
ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
Active Comparator: Cuff sealing by VE/VI ratio
VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured.
Procedure: VE/VI ratio of Spirometer
ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracuff Pressure
Time Frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
The intracuff pressure of endotracheal tube when cuff sealing is achieved.
From the start of cuff inflation to the airway sealing, an average of 2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracuff air volume
Time Frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
The intracuff air volume of endotracheal tube when cuff sealing is achieved.
From the start of cuff inflation to the airway sealing, an average of 2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Investigators

  • Principal Investigator: Junyong In, MD, PhD, DongGuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Actual)

October 29, 2018

Study Completion (Actual)

October 29, 2018

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • J_In_2017-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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