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Not Yet RecruitingNCT07188038

The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics

The Impact of Low Versus High Positive End-Expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics During Pressure Support Ventilation: A Randomized Interventional Crossover Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Vastra Gotaland Region · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this interventional study is to evaluate the effect of different positive end-expiratory pressures (PEEP) on lung and diaphragm function in patients mechanically ventilated with pressure support ventilation in the intensive care unit. The main questions aim to answer: Does higher PEEP level affect diaphragm contractions and ventilatory efficiency? Does higher PEEP level limit inspiratory efforts? Does higher PEEP level affect lung compliance? The participants will be subjected to three different PEEP levels during pressure support ventilation: Low PEEP (4 cmH2O), Medium PEEP (10 cmH2O), High PEEP (16 cmH2O). The lung and diaphragm function will be evaluated using high-resolution esophageal manometry, electrical activity of the diaphragm, external diaphragm ultrasound and spirometric ventilator data.

Conditions

Interventions

TypeNameDescription
PROCEDURELow positive end-expiratory pressureLow (4 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.
PROCEDUREMedium positive end-expiratory pressureMedium (10 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.
PROCEDUREHigh positive end-expiratory pressureHigh(16 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.

Timeline

Start date
2025-10-01
Primary completion
2027-07-31
Completion
2027-12-31
First posted
2025-09-23
Last updated
2025-09-23

Locations

2 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT07188038. Inclusion in this directory is not an endorsement.