The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient
Study Details
Study Description
Brief Summary
This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patient was enrolled in the first day receiving mechanical ventilation in ICU. Patient was included to group A or group B. Group A patient will receive tidal volume of 6 ml/kg and group B patient will receive tidal volume of 10 ml/kg. The assignment was randomized. Followed for 3 days. After 24, 48, and 72 hours, patient blood will be collected to measure the interleukin value, and diaphragm dysfunction will be observed by the use of ultrasonography by expert doctor from radiology department. Data will be analyzed statistically if there is an effect of tidal volume difference on diaphragm dysfunction and interleukin-6 as marker of inflammation. The minimal sample of patient is 44 patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: The six The group who received tidal volume of 6 ml/kg from mechanical ventilation |
Other: 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.
|
| Active Comparator: The ten The group who received tidal volume of 10 ml/kg from mechanical ventilation |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- DD-24 [24 hours after mechanical ventilation]
Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
- DD-48 [48 hours after mechanical ventilation]
Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
- DD-72 [72 hours after mechanical ventilation]
Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.
Secondary Outcome Measures
- IL-6-24 [24 hours after mechanical ventilation]
Blook interleukin 6 24 hours after mechanical ventilation
- IL-6-48 [48 hours after mechanical ventilation]
Blook interleukin 6 48 hours after mechanical ventilation
- IL-6-72 [72 hours after mechanical ventilation]
Blook interleukin 6 72 hours after mechanical ventilation
Other Outcome Measures
- Discharge outcome [Up to three months after mechanical ventilation]
The outcome at hospital discharge (alive or death)
- LOS in hospital [Up to three months after mechanical ventilation]
Length of stay (days) in hospital
- LOS in ICU [Up to three months after mechanical ventilation]
Length of stay (days) in ICU
- Weaning failure [Up to three months after mechanical ventilation]
The condition where patient failed for spontaneous breathing trial after mechanical ventilation. Grouped into success/failed.
- Intubation time [At extubation after mechanical ventilation]
Time (hours) long when a patient was intubated
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Minimum age 18 years old
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Critically ill patients
Exclusion Criteria:
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Patient with ARDS (PaO2/FiO2 <200)
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Pregnant woman
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Patient with history of cardiac or thorax surgery 14 days prior to admission
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Patient with severe peripheral musculoskeletal conditions
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Patient with prolonged in-hospital stay (>2 weeks) in the last 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | Indonesia | 10430 |
Sponsors and Collaborators
- Dr Cipto Mangunkusumo General Hospital
Investigators
- Study Chair: Dita Aditianingsih, Dr, Dr Cipto Mangunkusumo Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.
- 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. Review.
- 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. Review.
- Tremblay LN, Slutsky AS. Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. Epub 2005 Oct 18. Review.
- 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. Review.
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