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

NCT ID: NCT06689020

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-07-01

Brief Summary

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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

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Conditions

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Recruitment Respiratory Failure

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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

During application of CPEP and CHFO, EIT is monitored.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Denise Battaglini

UNKNOWN

Sponsor Role collaborator

University of Genova

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Ball

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Genova, GE, Italy

Site Status

Countries

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Italy

Central Contacts

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Denise Battaglini, MD, PhD

Role: CONTACT

+39-0105554970

Lorenzo Ball, MD, PhD

Role: CONTACT

+39-0105554970

Facility Contacts

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Denise Battaglini, MD, PhD

Role: primary

+39-0105554970

Lorenzo Ball, MD, PhD

Role: backup

+39-0105554970

References

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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.

Reference Type RESULT
PMID: 37097986 (View on PubMed)

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.

Reference Type RESULT
PMID: 31410738 (View on PubMed)

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.

Reference Type RESULT
PMID: 34063429 (View on PubMed)

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.

Reference Type RESULT
PMID: 29485340 (View on PubMed)

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.

Reference Type RESULT
PMID: 31113857 (View on PubMed)

Other Identifiers

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PEP-RECRUIT

Identifier Type: -

Identifier Source: org_study_id

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