Status:
NOT_YET_RECRUITING
The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Sahlgrenska University Hospital
Göteborg University
Conditions:
Respiratory Failure
ARDS (Acute Respiratory Distress Syndrome)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07188038
Start Date
October 1 2025
End Date
December 31 2027
Last Update
September 23 2025
Active Locations (2)
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1
Central intensivvårdsavdelning, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 45
2
Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalandsregionen
Gothenburg, Västra Götaland County, Sweden, 413 45