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

Not Applicable

Completed

• Conditions: Aspiration, Respiratory; Nursing Caries; Mechanical Ventilation Complication; Ventilator Associated Pneumonia
• Interventions: Device: Manometer; Device: Smart Cuff Manager

• Registration Number: NCT04061083
• Lead Sponsor: Afyonkarahisar Health Sciences University

Brief Summary

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

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 Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-04
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Endotracheal Cuff Pressure Control	Manometer	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
Continuous Endotracheal Cuff Pressure Control	Smart Cuff Manager	Continuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit

Primary Outcome Measures

Name	Time	Method
Microaspiration of Gastric Contents	From randomisation to 48 hours after intubation	The unintentional aspiration of very small amounts of gastric contents

Trial Locations

Locations (1)

Özlem SOYER; 🇹🇷 Afyonkarahisar, Center, Turkey