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Completed

NCT Number: NCT04061083

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

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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Key information

Conditions

Mechanical Ventilation Complication Aspiration, Respiratory Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Nursing Caries Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özlem SOYER

Afyonkarahisar, Center, 03200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smart Cuff Manager

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

manometer

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

Primary outcomes

  1. Microaspiration of Gastric Contents

    Time frame: From randomisation to 48 hours after intubation

    The unintentional aspiration of very small amounts of gastric contents

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Collaborators

  • Afyonkarahisar Health Sciences University Hospital
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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