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

Sponsor
Vastra Gotaland Region
Study ID
NCT07188038
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 23, 2025
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Low PEEP
    Low positive end-expiratory pressure (4 cmH2O)
  • Experimental: Medium PEEP
    Medium positive end-expiratory pressure (10 cmH2O)
  • Experimental: High PEEP
    High positive end-expiratory pressure (16 cmH2O)

Primary Outcome Measure

Inspiratory effort [ Time Frame: Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level ]

Central Contacts

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