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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061083
• Other study ID #: 118S409
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2023
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Özlem SOYER	Afyonkarahisar	Center

Sponsors (3)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University	Afyonkarahisar Health Sciences University Hospital, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microaspiration of Gastric Contents	The unintentional aspiration of very small amounts of gastric contents	From randomisation to 48 hours after intubation