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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Vastra Gotaland Region • ClinicalTrials.gov ID: NCT07188038

Registry updated: 2026-09-02
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Description

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.

Interventions

  • Low positive end-expiratory pressure (Procedure)
    Low (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.
  • Medium positive end-expiratory pressure (Procedure)
    Medium (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.
  • High positive end-expiratory pressure (Procedure)
    High(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.

Eligibility criteria

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

Conditions

Respiratory Failure ARDS (Acute Respiratory Distress Syndrome) Pneumonia Respiratory Insufficiency

Locations

  • Central intensivvårdsavdelning, Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden
  • Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalandsregionen — Gothenburg, Västra Götaland County, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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