Endotracheal Tube Cuff Inflation Pressure Varieties and Response to Education Among Anesthetists

August 29, 2021 updated by: Abdelrhman Alshawadfy, Suez Canal University

Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients.

This study will investigate the endotracheal ETT cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply.

Study Overview

Detailed Description

Although the increasing uses of different supraglottic devices as an alternative, the traditional endotracheal intubation is still considered the commonly used method for managing the airway of a generally anaesthetized patient. After passing the endotracheal tube through the larynx, the anaesthetist inflates the cuff or asks the anaesthesia technician to inflate it. How much air is injected into the cuff is not a major concern for almost all anaesthetists and they usually depend on palpating the external cuff tense to judge is it too much, accurate or not enough? Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. Inflation of the cuff of pressure more than 30 cm H2O can damage the tracheal mucosa by compromising capillary perfusion. When pressures are greater than 50 cm H2O, total obstruction of tracheal blood flow occurs. For long times, without any evidence-based data, it has been believed that well-trained anaesthetists are capable of determining proper ETT cuff pressures. It is presumed that anaesthetists can detect appropriate inflation pressure and overinflated ETT cuff by palpating the ETT pilot balloon. Adequacy of cuff inflation is conventionally determined by palpation of the external balloon. Previous studies suggest that this approach is unreliable. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. However, increased awareness of over-inflation risks may have improved recent clinical practice.

The aim of the work: This study will investigate the endotracheal cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply. Material and Methods: Type of the study: Prospective controlled single-blind study. Settings: After obtaining approval by the Ethics Committee of the Suez Canal University Hospital, and written informed consent with an explanation regarding the purpose, effects, technique, and complications, all anaesthetists, working currently in the facility, are included.

Study Type

Interventional

Enrollment (Actual)

28

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

      • Ismailia, Egypt, 2685
        • Suez Canal University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • anaesthetists
  • works at Suez canal university hospital
  • resident, registrar, or senior registrar

Exclusion Criteria:

  • refusal to participate
  • who will not complete the 2 rounds 3 readings each

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Before education

Before alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff.

This is before applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure.

Before applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.
Active Comparator: After education

After alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff.

This is after applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure.

After applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy in inflating the cuff of the endotracheal tubes
Time Frame: immediately after fixation of the endotracheal tube during general anaethesia
assessment of the Anesthetists' accuracy in inflating the cuff of the endotracheal tubes used to maintain the airway of generally anaesthetized patients the change following feedback.
immediately after fixation of the endotracheal tube during general anaethesia

Collaborators and Investigators

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

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)

January 1, 2018

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 29, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ETT cuff pressure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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