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

Not yet recruiting

• Conditions: Recruitment; Respiratory Failure

• Registration Number: NCT06689020
• Lead Sponsor: University of Genova

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Study Start: 2024-12-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess changes in systemic oxygenation	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	Arterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)
Changes in lung recruitment using EIT	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	Absolute reduction in the percentage (%) of lung volume collapse assessed with the electrical impedance tomography (EIT)

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure, mmHg	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	Heart rate as measured by continuous pressure monitoring
Heart rate min-1	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	Heart rate as measured by continuous electrocardiogram monitoring

Trial Locations

Locations (1)

UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, GE, Italy