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

Primary Purpose

Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Nursing Caries

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Smart Cuff Manager

Manometer

About this trial

This is an interventional prevention trial for Mechanical Ventilation Complication focused on measuring Intensive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Özlem SOYER

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Continuous Endotracheal Cuff Pressure Control

Intermittent Endotracheal Cuff Pressure Control

Standard Care

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Microaspiration of Gastric Contents

The unintentional aspiration of very small amounts of gastric contents

Secondary Outcome Measures

Full Information

NCT ID

NCT04061083

First Posted

August 15, 2019

Last Updated

February 4, 2023

Sponsor

Afyonkarahisar Health Sciences University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04061083

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

May 16, 2019 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Afyonkarahisar Health Sciences University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Intensive Care

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Endotracheal Cuff Pressure Control

Arm Type

Experimental

Arm Description

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

Arm Title

Intermittent Endotracheal Cuff Pressure Control

Arm Type

Experimental

Arm 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

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Smart Cuff Manager

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Manometer

Intervention Description

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 Outcome Measure Information:

Title

Microaspiration of Gastric Contents

Description

The unintentional aspiration of very small amounts of gastric contents

Time Frame

From randomisation to 48 hours after intubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Özlem SOYER

City

Afyonkarahisar

State/Province

Center

ZIP/Postal Code

03200

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36002981

Citation

Er OS, Van Giersbergen MY, Celik S. Effects of three endotracheal tube cuff pressure control measures on microaspiration of gastric content: Study protocol for randomised controlled trial. J Clin Nurs. 2023 Apr;32(7-8):1476-1486. doi: 10.1111/jocn.16493. Epub 2022 Aug 24.

Results Reference

derived

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

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