The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient
NCT ID: NCT05370248
Last Updated: 2022-05-11
Study Results
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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UNKNOWN
NA
44 participants
INTERVENTIONAL
2021-09-01
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
The person assigning patients to each group is the research assistant. The person setting the mechanical ventilator is the anesthesiology resident. The person assessing outcome with ultrasound is radiology department staff, who does not know which group the patient belong.
The person assessing outcome of interleukin is laboratory personnel, who does not know which group the patient belong.
The person collecting and freezing data into worksheet is the research assistant.
The person analyzing final data is the primary investigator.
Study Groups
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The six
The group who received tidal volume of 6 ml/kg from mechanical ventilation
Tidal volume 6 ml/kg
Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.
The ten
The group who received tidal volume of 10 ml/kg from mechanical ventilation
Tidal volume 10 ml/kg
Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.
Interventions
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Tidal volume 6 ml/kg
Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.
Tidal volume 10 ml/kg
Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.
Eligibility Criteria
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Inclusion Criteria
* Critically ill patients
Exclusion Criteria
* Pregnant woman
* Patient with history of cardiac or thorax surgery 14 days prior to admission
* Patient with severe peripheral musculoskeletal conditions
* Patient with prolonged in-hospital stay (\>2 weeks) in the last 3 months
18 Years
ALL
No
Sponsors
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Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Darma Putra Sitepu
Anesthesiologist Consultant In-Training, Principal Investigator
Principal Investigators
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Dita Aditianingsih, Dr
Role: STUDY_CHAIR
Dr Cipto Mangunkusumo Hospital
Locations
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Dr Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.
Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.
Mehta AB, Syeda SN, Wiener RS, Walkey AJ. Epidemiological trends in invasive mechanical ventilation in the United States: A population-based study. J Crit Care. 2015 Dec;30(6):1217-21. doi: 10.1016/j.jcrc.2015.07.007. Epub 2015 Jul 16.
Tremblay LN, Slutsky AS. Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. doi: 10.1007/s00134-005-2817-8. Epub 2005 Oct 18. No abstract available.
Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
Petrof BJ. Diaphragm Weakness in the Critically Ill: Basic Mechanisms Reveal Therapeutic Opportunities. Chest. 2018 Dec;154(6):1395-1403. doi: 10.1016/j.chest.2018.08.1028. Epub 2018 Aug 23.
Other Identifiers
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DPS1
Identifier Type: -
Identifier Source: org_study_id
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