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

NCT04061083 | Completed

• 1 other identifier: 118S409
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Intensive Care

Outcome Measures

Primary Outcomes (1)

• Microaspiration of Gastric Contents

  The unintentional aspiration of very small amounts of gastric contents

  From randomisation to 48 hours after intubation

Study Arms (3)

Continuous Endotracheal Cuff Pressure Control

EXPERIMENTAL

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

Device: Smart Cuff Manager

Intermittent Endotracheal Cuff Pressure Control

EXPERIMENTAL

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

Device: Manometer

Standard Care

NO INTERVENTION

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

Interventions

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

Continuous Endotracheal Cuff Pressure Control

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

Intermittent Endotracheal Cuff Pressure Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Özlem SOYER

Afyonkarahisar, Center, 03200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36002981 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assisstant, Msc, RN

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: May 16, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)