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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04061083
Enrollment
135
Registered
2019-08-19
Start date
2019-05-16
Completion date
2019-12-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Intensive Care

Brief summary

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

Detailed 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.

Interventions

DEVICESmart 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

DEVICEManometer

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

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Afyonkarahisar Health Sciences University Hospital
CollaboratorUNKNOWN
Afyonkarahisar Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microaspiration of Gastric ContentsFrom randomisation to 48 hours after intubationThe unintentional aspiration of very small amounts of gastric contents

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026