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

Afyonkarahisar Health Sciences University

Status: Completed

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

Treatments: Device: Smart Cuff Manager; Device: Manometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04061083

118S409

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Continuous Endotracheal Cuff Pressure Control

Experimental group

Description:

Continuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit

Treatment:

Device: Smart Cuff Manager

Intermittent Endotracheal Cuff Pressure Control

Experimental group

Description:

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

Treatment:

Device: Manometer

Standard Care

No Intervention group

Description:

ET cuff pressure control will be provided with pilot balloon fingers during the first 48 hours of intubation in the intensive care unit