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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2019-12-01

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.

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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.

Conditions

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Mechanical Ventilation Complication Ventilator Associated Pneumonia Nursing Caries Aspiration, Respiratory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Smart Cuff Manager

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Manometer

Intervention Type DEVICE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No