Trials / Completed
CompletedNCT04061083
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Afyonkarahisar Health Sciences University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Mechanical Ventilation Complication
- Ventilator Associated Pneumonia
- Nursing Caries
- Aspiration, Respiratory
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DEVICE | 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 |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2019-08-19
- Last updated
- 2023-02-08
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04061083. Inclusion in this directory is not an endorsement.