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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06689020
Acronym
PEP-RECRUIT
Enrollment
26
Registered
2024-11-14
Start date
2024-12-01
Completion date
2025-07-01
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recruitment, Respiratory Failure

Brief summary

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.

Interventions

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

During application of CPEP and CHFO, EIT is monitored.

Sponsors

Denise Battaglini
CollaboratorUNKNOWN
University of Genova
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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) * Inability to properly position the EIT device for anatomical reasons

Design outcomes

Primary

MeasureTime frameDescription
To assess changes in systemic oxygenationImmediately 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 treatmentArterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)
Changes in lung recruitment using EITImmediately 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 treatmentAbsolute reduction in the percentage (%) of lung volume collapse assessed with the electrical impedance tomography (EIT)

Secondary

MeasureTime frameDescription
Mean arterial pressure, mmHgImmediately 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 treatmentHeart rate as measured by continuous pressure monitoring
Heart rate min-1Immediately 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 treatmentHeart rate as measured by continuous electrocardiogram monitoring

Countries

Italy

Contacts

Primary ContactDenise Battaglini, MD, PhD
battaglini.denise@gmail.com+39-0105554970
Backup ContactLorenzo Ball, MD, PhD
lorenzo.ball@unige.it+39-0105554970

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026