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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Recruitment
• Intervention / Treatment: Procedure: Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy

• Study Type: Observational
• Enrollment (Estimated): 26

Contacts and Locations

• Study Contact: Name: Denise Battaglini, MD, PhD; Phone Number: +39-0105554970; Email: battaglini.denise@gmail.com
• Study Contact Backup: Name: Lorenzo Ball, MD, PhD; Phone Number: +39-0105554970; Email: lorenzo.ball@unige.it

Study Locations

• Italy
  • GE
    • Genova, GE, Italy, 16132
      • UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino
      • Contact: Denise Battaglini, MD, PhD; Phone Number: +39-0105554970; Email: battaglini.denise@gmail.com
      • Contact: Lorenzo Ball, MD, PhD; Phone Number: +39-0105554970; Email: lorenzo.ball@unige.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure, mmHg	Heart rate as measured by continuous pressure monitoring	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 min-1	Heart rate as measured by continuous electrocardiogram monitoring	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

Collaborators and Investigators

• Sponsor: University of Genova
• Collaborators: Denise Battaglini

Publications and helpful links

General Publications

• Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.
• Jonkman AH, Alcala GC, Pavlovsky B, Roca O, Spadaro S, Scaramuzzo G, Chen L, Dianti J, Sousa MLA, Sklar MC, Piraino T, Ge H, Chen GQ, Zhou JX, Li J, Goligher EC, Costa E, Mancebo J, Mauri T, Amato M, Brochard LJ; Pleural Pressure Working Group (PLUG). Lung Recruitment Assessed by Electrical Impedance Tomography (RECRUIT): A Multicenter Study of COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2023 Jul 1;208(1):25-38. doi: 10.1164/rccm.202212-2300OC.
• Longhini F, Maugeri J, Andreoni C, Ronco C, Bruni A, Garofalo E, Pelaia C, Cavicchi C, Pintaudi S, Navalesi P. Electrical impedance tomography during spontaneous breathing trials and after extubation in critically ill patients at high risk for extubation failure: a multicenter observational study. Ann Intensive Care. 2019 Aug 13;9(1):88. doi: 10.1186/s13613-019-0565-0.
• Battaglini D, Caiffa S, Gasti G, Ciaravolo E, Robba C, Herrmann J, Gerard SE, Bassetti M, Pelosi P, Ball L, On Behalf Of The Gecovid Group. An Experimental Pre-Post Study on the Efficacy of Respiratory Physiotherapy in Severe Critically III COVID-19 Patients. J Clin Med. 2021 May 15;10(10):2139. doi: 10.3390/jcm10102139.
• Reychler G, Uribe Rodriguez V, Hickmann CE, Tombal B, Laterre PF, Feyaerts A, Roeseler J. Incentive spirometry and positive expiratory pressure improve ventilation and recruitment in postoperative recovery: A randomized crossover study. Physiother Theory Pract. 2019 Mar;35(3):199-205. doi: 10.1080/09593985.2018.1443185. Epub 2018 Feb 27.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: PEP-RECRUIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No