Clinical trial NCT05370248: The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient
Official title: The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: Mechanical ventilation
Diaphragm dysfunction
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient was divided into group A and B. Group A received tidal volume of 6 ml/kg and group B received tidal volume of 10 ml/kg.
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Minimum age 18 years old
* Critically ill patients

Exclusion Criteria:

* Patient with ARDS (PaO2/FiO2 \<200)
* 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

Primary outcomes:
measure: DD-24
timeFrame: 24 hours after mechanical ventilation
measure: DD-48
timeFrame: 48 hours after mechanical ventilation
measure: DD-72
timeFrame: 72 hours after mechanical ventilation
Secondary outcomes:
measure: IL-6-24
timeFrame: 24 hours after mechanical ventilation
measure: IL-6-48
timeFrame: 48 hours after mechanical ventilation
measure: IL-6-72
timeFrame: 72 hours after mechanical ventilation
Other outcomes:
measure: Discharge outcome
timeFrame: Up to three months after mechanical ventilation
measure: LOS in hospital
timeFrame: Up to three months after mechanical ventilation
measure: LOS in ICU
timeFrame: Up to three months after mechanical ventilation
measure: Weaning failure
timeFrame: Up to three months after mechanical ventilation
measure: Intubation time
timeFrame: At extubation after mechanical ventilation
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Dr Cipto Mangunkusumo Hospital
name: Dita Aditianingsih, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.