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

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

Detailed Description
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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.

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

Conditions
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Nursing Caries, Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Aspiration, Respiratory

Intervention / Treatment
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* Device: Smart Cuff Manager
* Device: Manometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Endotracheal Cuff Pressure Control<br>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<br>* 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<br>|
| Experimental: Intermittent Endotracheal Cuff Pressure Control<br>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<br>* 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<br>|
| No Intervention: Standard Care<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care