Effects of Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents

February 4, 2023 updated by: Özlem SOYER, Afyonkarahisar Health Sciences University

Effects of Three Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents: a Randomized Controlled Trial

The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).

To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.

Study Type

Interventional

Enrollment (Actual)

135

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

  • Turkey
    • Center
      • Afyonkarahisar, Center, Turkey, 03200
        • Özlem SOYER

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering of the patient or relatives who will participate in the study,
  • Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.

Exclusion Criteria:

  • Patients who are contraindicated in giving a semi-fowler position,
  • Patients with enteral nutrition contraindications,
  • Patients connected to mechanical ventilators for more than 48 hours,
  • Patients with tracheostomy,
  • Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
  • Nasal endotracheal intubation.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous Endotracheal Cuff Pressure Control
Continuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit
Device: Smart Cuff Manager
Participant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit
EXPERIMENTAL: Intermittent Endotracheal Cuff Pressure Control
Intermittent cuff pressure control through manual manometer measurement performed 3 times per day during the first 48 hours of intubation in the intensive care unit
Device: Manometer
Participant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit
NO_INTERVENTION: Standard Care
ET cuff pressure control will be provided with pilot balloon fingers during the first 48 hours of intubation in the intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microaspiration of Gastric Contents
Time Frame: From randomisation to 48 hours after intubation
The unintentional aspiration of very small amounts of gastric contents
From randomisation to 48 hours after intubation

Collaborators and Investigators

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

Sponsor

Afyonkarahisar Health Sciences University

Collaborators

The Scientific and Technological Research Council of Turkey
Afyonkarahisar Health Sciences University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 16, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (ACTUAL)

August 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118S409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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