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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Circulatory instability

Brain death diagnosis/brain death evaluation

Norepinephrine dose > 0.4 µg/kg/min

Muscle relaxation administered within 2 hours

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low positive end-expiratory pressure

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: Low PEEPExperimental treatment 1 intervention
Group B: Medium PEEPExperimental treatment 1 intervention
Group C: High PEEPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Inspiratory effort

Inspiratory effort will be measured by the tidal change in esophageal pressure (in cmH2O) during assisted breathing. The esophageal pressure will be measured using a high-resolution manometry catheter. The change from expiratory to inspiratory esophageal pressure will represent the tidal change and be used to estimate the inspiratory effort.

Time frame
Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level
2

Inspiratory drive

The electric activity of the diaphragm (Eadi) will be measured using a NAVA (neurally adjusted ventilatory assist) catheter. The change from end-expiratory to inspiratory Eadi will be calculated. This represents the inspiratory drive. The Eadi will be measured in Voltage.

Time frame
Measured during 5 uninterrupted breaths 10 minutes after application of interventional PEEP level
3

Effort-to-drive ratio

The effort-to-drive ratio (EDR) will be calculated as the inspiratory effort (tidal change in esophageal pressure) divided by the inspiratory drive (tidal change in electric activity of the diaphragm).

Time frame
Calculated from the measures collected 10 minutes after application of interventional PEEP level
4

Neuromechanical efficiency

The neuromechanical efficiency will be calculated as the change in airway pressure during an occlusion test (Pocc) (measured from end-expiration to maximum negative pressure during the occlusion manoeuvre) divided by the inspiratory change in electric activity of the diaphragm (from end-expiration to inspiration).

Time frame
Calculated from the measures collected during the occlusion manoeuvre performed 10-15 minutes after application of interventional PEEP level

Secondary outcomes

1

Airway driving pressure

Difference in airway pressure between end-expiration and during an inspiratory hold will be calculated from the ventilator data.

Time frame
Measured during an inspiratory hold performed 10-15 minutes after application of interventional PEEP level
2

Lung compliance

Lung compliance will be calculated as the tidal volume divided by the change in transpulmonary pressure from end-expiration to end-inspiration.

Time frame
Measured during an inspiratory hold performed 10 - 15 minutes after application of interventional PEEP level
3

Thickening fraction of the expiratory abdominal muscles (TFabd)

The abdominal muscles will be visualized by ultrasound in the anterior axillary line, midway between the inferior border of the ribcage and the iliac crest. The thickening fraction will be calculated as \[(expiratory thickness - end-inspiratory thickness) / end-inspiratory thickness \].

Time frame
Measured 10 minutes after application of interventional PEEP level
4

Oxygenation

The PFI (PaO2/FiO2 ratio) will be calculated as arterial PaO2 (partial pressure of oxygen) divided by the FiO2 (fraction of inspired oxygen)

Time frame
The blood gas will be collected 10 minutes after application of interventional PEEP level

Other outcomes

1

Central venous oxygen saturation (ScvO2)

Oxygen saturation of venous blood drawn from a central venous catheter.

Time frame
Venous blood gas will be collected 10 minutes after application of interventional PEEP level
2

Tidal volume

The volume change from end-expiration to end-inspiration. Will be acquired from the ventilator.

Time frame
Measured in 5 breaths 10 minutes after the application of interventional PEEP level.
3

Respiratory rate

The number of breaths per minutes (respiratory rate) will be calculated from the volume-time curve acquired from the ventilator.

Time frame
Measured 10 minutes after the application of interventional PEEP level.
4

Dead space

Dead space (volume of gas not participating in gas exchange) will be calculated from the difference between arterial and end-expiratory partial pressure of Carbon dioxide, using blood gas analysis and capnography.

Time frame
The dead space will be calculated 10 minuted after application of interventional PEEP level.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Sahlgrenska University Hospital

Collaborator

Göteborg University

Collaborator