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NCT04061083 Clinical Trial

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

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04061083
Other study ID # 118S409
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2019
Est. completion date December 1, 2019

Study information
Verified date February 2023
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Turkey Özlem SOYER Afyonkarahisar Center

Sponsors (3)
Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University Afyonkarahisar Health Sciences University Hospital, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microaspiration of Gastric Contents The unintentional aspiration of very small amounts of gastric contents From randomisation to 48 hours after intubation
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