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NCT Number: NCT06689020

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

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.

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Key information

Conditions

Recruitment Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

During application of CPEP and CHFO, EIT is monitored.

Primary outcomes

  1. To assess changes in systemic oxygenation

    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

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

  2. Changes in lung recruitment using 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

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

Secondary outcomes

  1. Mean arterial pressure, 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

    Heart rate as measured by continuous pressure monitoring

  2. Heart rate min-1

    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

    Heart rate as measured by continuous electrocardiogram monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Battaglini, MD, PhD

CONTACT

[email protected]

+39-0105554970

Lorenzo Ball, MD, PhD

CONTACT

[email protected]

+39-0105554970

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Collaborators

  • Denise Battaglini

Registry information

Official study title

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

Acronym: PEP-RECRUIT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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