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

Afyonkarahisar Health Sciences University135 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

135

Conditions

Mechanical Ventilation Complication Ventilator Associated Pneumonia Nursing Caries Aspiration, Respiratory

Interventions

Smart Cuff ManagerDEVICE

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

ManometerDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Özlem SOYER

Afyonkarahisar, Center, Turkey (Türkiye)

Outcomes

Primary Outcomes

Microaspiration of Gastric Contents

The unintentional aspiration of very small amounts of gastric contents

Time frame: From randomisation to 48 hours after intubation

Data from ClinicalTrials.gov

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