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

NCT06689020 | Not Yet Recruiting

• 1 other identifier: PEP-RECRUIT
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Recruitment; Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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 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

Interventions

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

During application of CPEP and CHFO, EIT is monitored.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who require pulmonary expansion and airway clearing as per clinical indication
• Patients who provide valid informed consent according to local regulations
• Patient on the Airway Care Score (ACS) \< 7

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead
• Denise Battaglini: collaborator

Study Sites (1)

UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

Related Publications (5)

• 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.

  PMID: 37097986 RESULT

• 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.

  PMID: 31410738 RESULT

• 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.

  PMID: 34063429 RESULT

• 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.

  PMID: 29485340 RESULT

• 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.

  PMID: 31113857 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

cholesterylphosphorylethylpyridinium; Therapeutics

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Denise Battaglini, MD, PhD

CONTACT

+39-0105554970; battaglini.denise@gmail.com

Lorenzo Ball, MD, PhD

CONTACT

+39-0105554970; lorenzo.ball@unige.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)