The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation… (NCT07188038) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics
Sweden25 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mechanical ventilation with pressure support or mechanical ventilation with possibility to transition to pressure support
* Oxygen requirement ≤ 50%
* Pressure support ≤ 12 cmH2O
* PEEP ≤ 12 cmH2O
* Age ≥ 18 years
* Adequate intravascular volume status
Exclusion Criteria:
* Circulatory instability
* Brain death diagnosis/brain death evaluation
* Norepinephrine dose \> 0.4 µg/kg/min
* Muscle relaxation administered within 2 hours
* Pregnancy
* Contraindication to esophageal catheterization (e.g., esophageal varices)
* Conditions with increased risk of pneumothorax (such as severe COPD (Chronic Obstructive Pulmonary Disease) or extensive emphysema)
* Untreated pneumothorax
* Symptomatic airway obstruction
Discontinuation criteria during ongoing study intervention:
* Heart rate \> 120 beats/min
* Systolic blood pressure \> 180 mmHg
* Inspired oxygen fraction \> 70%
* Respiratory rate \> 35/min
* RASS (Richmond Agitation Sedation Scale) ≥ 2
* Doubling of norepinephrine dose or increase of norepinephrine dose to \> 0.5 µg/kg/min to maintain mean arterial pressure
* Bradycardia \< 45 beats/min
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inspiratory effort
Timeframe: Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level
2
Inspiratory drive
Timeframe: Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level
3
Effort-to-drive ratio
Timeframe: Calculated from the measures collected 10 minutes after application of interventional PEEP level
4
Neuromechanical efficiency
Timeframe: Calculated from the measures collected during the occlusion manoeuvre performed 10-15 minutes after application of interventional PEEP level
5
Thickening fraction of the diaphragm (TFdi)
Timeframe: Measured 10 minutes after application of interventional PEEP level
6
Transpulmonary driving pressure
Timeframe: Measured during 5 breaths 10 minutes after application of interventional PEEP level
Timeframe: The occlusion pressure will be measured during an occlusion manoeuvre performed 10-15 minutes after application of interventional PEEP level.