Positive Expiratory Pressure (PEP) and Continuous High-frequency Oscillation (CHFO) on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Genova

About this trial

This single-center observational study aims to assess the effects of continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy on lung recruitment using electrical impedance tomography (EIT) in spontaneously breathing patients admitted to the intensive care unit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who require pulmonary expansion and airway clearing as per clinical indication

Patients who provide valid informed consent according to local regulations

PaO2/FiO2 < 200 mmHg at inclusion

Patient on the Airway Care Score (ACS) < 7

Disqualifiers

Refuse to participate

Age < 18 years

Hemodynamic instability, defined as systolic arterial pressure < 90 mmHg or mean pressure < 60 mmHg

Contraindication to using an EIT (i.e., pacemaker or defibrillator)

Trial population

Patients who are spontaneously breathing and admitted to the intensive care unit

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy

    Procedure/Surgery

    During application of CPEP and CHFO, EIT is monitored.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

To assess changes in systemic oxygenation

Arterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)

Time frame
Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment
2

Changes in lung recruitment using EIT

Absolute reduction in the percentage (%) of lung volume collapse assessed with the electrical impedance tomography (EIT)

Time frame
Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment

Secondary outcomes

1

Mean arterial pressure, mmHg

Heart rate as measured by continuous pressure monitoring

Time frame
Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment
2

Heart rate min-1

Heart rate as measured by continuous electrocardiogram monitoring

Time frame
Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment

Other outcomes

Sponsors and contacts

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

University of Genova

Lead sponsor

Denise Battaglini

Collaborator

This trial is not recruiting at the moment. You can still explore other options: