Impact of Low vs High PEEP on Diaphragm and Lung Function in Mechanically Ventilated Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will compare three PEEP levels (4, 10, and 16 cmH2O) in patients requiring mechanical ventilation with pressure support. Outcomes will include diaphragm activity and contractility, lung mechanics, and ventilator performance measured with esophageal manometry, diaphragm EMG, ultrasound, and ventilator data. The goal is to see if higher PEEP alters inspiratory effort, diaphragm function, or lung compliance during supported breathing. Safety monitoring includes predefined discontinuation criteria for instability or intolerance. The study is conducted in Swedish ICUs with central oversight by regional authorities and Sahlgrenska/Särelsen University Hospital collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Central intensivvårdsavdelning, Sahlgrenska University Hospital
  Gothenburg, Västra Götaland County, Sweden Recruiting
• Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalandsregionen
  Gothenburg, Västra Götaland County, Sweden Not yet recruiting

Study contacts

• Principal investigator: Hannes Widing — Anesthesia and intensive care medicine, Område 5, Sahlgrenska University hospital, Västra Götalandsregionen
• Study coordinator: Hannes Widing
• Email: hannes.widing@vgregion.se
• Phone: 0046703957374

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.