The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics
NCT ID: NCT07188038
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2025-10-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Low PEEP
Low positive end-expiratory pressure (4 cmH2O)
Low positive end-expiratory pressure
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 PEEP
Medium positive end-expiratory pressure (10 cmH2O)
Medium positive end-expiratory pressure
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 PEEP
High positive end-expiratory pressure (16 cmH2O)
High positive end-expiratory pressure
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.
Interventions
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Low positive end-expiratory pressure
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
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
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
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Inclusion Criteria
* Oxygen requirement ≤ 50%
* Pressure support ≤ 12 cmH2O
* PEEP ≤ 12 cmH2O
* Age ≥ 18 years
* Adequate intravascular volume status
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Hannes Widing
Role: PRINCIPAL_INVESTIGATOR
Anesthesia and intensive care medicine, Område 5, Sahlgrenska University hospital, Västra Götalandsregionen
Locations
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Central intensivvårdsavdelning, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalandsregionen
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-01286-01
Identifier Type: -
Identifier Source: org_study_id
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