Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation in ARDS Patients by EIT
1 other identifier
observational
30
1 country
1
Brief Summary
Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedNovember 8, 2022
June 1, 2022
2 years
April 5, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
tidal volume distribution during APRV at 24 hours after APRV
we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV
24 hours after APRV mechanical ventilation
Secondary Outcomes (30)
tidal volume distribution during APRV
Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation
Intrapulmonary shunt during APRV
Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
V/Q match
Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
tidal volume(Vt)
Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Plateau pressure
Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
- +25 more secondary outcomes
Eligibility Criteria
Include as many subjects as possible according to the research protocol
You may qualify if:
- years old \< age \< 80 years old
- Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
- Predicted APRV mechanical ventilation for more than 72 hours
You may not qualify if:
- APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
- Pregnant women
- Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
- Refractory shock
- BMI\>35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Related Publications (5)
Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
PMID: 28936695BACKGROUNDBellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PMID: 26903337RESULTMauri T, Spinelli E, Scotti E, Colussi G, Basile MC, Crotti S, Tubiolo D, Tagliabue P, Zanella A, Grasselli G, Pesenti A. Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386.
PMID: 32697482RESULTSafaee Fakhr B, Araujo Morais CC, De Santis Santiago RR, Di Fenza R, Gibson LE, Restrepo PA, Chang MG, Bittner EA, Pinciroli R, Fintelmann FJ, Kacmarek RM, Berra L. Bedside monitoring of lung perfusion by electrical impedance tomography in the time of COVID-19. Br J Anaesth. 2020 Nov;125(5):e434-e436. doi: 10.1016/j.bja.2020.08.001. Epub 2020 Aug 7. No abstract available.
PMID: 32859359RESULTKollisch-Singule M, Emr B, Smith B, Ruiz C, Roy S, Meng Q, Jain S, Satalin J, Snyder K, Ghosh A, Marx WH, Andrews P, Habashi N, Nieman GF, Gatto LA. Airway pressure release ventilation reduces conducting airway micro-strain in lung injury. J Am Coll Surg. 2014 Nov;219(5):968-76. doi: 10.1016/j.jamcollsurg.2014.09.011. Epub 2014 Sep 19.
PMID: 25440027RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
xiaojing zou, PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2022
First Posted
June 6, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
November 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share