RecruitmentPEP-RECRUITNCT06689020
Positive Expiratory Pressure (PEP) and Continuous High-frequency Oscillation (CHFO) on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study
An observational study of Recruitment and Respiratory Failure, run by University of Genova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recruitment, Respiratory Failure
- What is being tested?
- Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are spontaneously breathing and admitted to the intensive care unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Denise Battaglini, MD, PhD, +39-0105554970, battaglini.denise@gmail.com
Lorenzo Ball, MD, PhD, +39-0105554970, lorenzo.ball@unige.it
About this study
Official 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
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
- Being tested
- Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapyProcedure or surgery
During application of CPEP and CHFO, EIT is monitored.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes in systemic oxygenation
Arterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)
Measured: 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)
Measured: 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
Heart rate as measured by continuous pressure monitoring
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Collaborators
- Denise Battaglini
- Responsible party
- Principal investigator, Lorenzo Ball, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689020
- Sponsor's protocol ID
- PEP-RECRUIT
- Acronym
- PEP-RECRUIT
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37097986Longhini 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.
PubMed 31410738Battaglini 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.
PubMed 34063429Reychler 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.
PubMed 29485340Rowley 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.
PubMed 31113857
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06689020
- Acronym / sponsor ID
- PEP-RECRUIT / PEP-RECRUIT
- Conditions
- Recruitment, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Collaborators
- Denise Battaglini
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are spontaneously breathing and admitted to the intensive care unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapyDuring application of CPEP and CHFO, EIT is monitored. | Procedure or surgery | – |
Primary outcome
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)
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)
2 secondary outcomes
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Results publication: PubMed 37097986Jonkman 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.
- Results publication: PubMed 31410738Longhini 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.
- Results publication: PubMed 34063429Battaglini 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.
- Results publication: PubMed 29485340Reychler 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.
- Results publication: PubMed 31113857Rowley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recruitment and Respiratory Failure, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Battaglini, MD, PhD (+39-0105554970, battaglini.denise@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689020, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.