The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05370248
• Other study ID #: DPS1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: May 2022
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Dr Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

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. — View 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. — View 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. — View Citation

Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61. — View 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. Review. — View 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. Review. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discharge outcome	The outcome at hospital discharge (alive or death)	Up to three months after mechanical ventilation
Other	LOS in hospital	Length of stay (days) in hospital	Up to three months after mechanical ventilation
Other	LOS in ICU	Length of stay (days) in ICU	Up to three months after mechanical ventilation
Other	Weaning failure	The condition where patient failed for spontaneous breathing trial after mechanical ventilation. Grouped into success/failed.	Up to three months after mechanical ventilation
Other	Intubation time	Time (hours) long when a patient was intubated	At extubation after mechanical ventilation
Primary	DD-24	Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.	24 hours after mechanical ventilation
Primary	DD-48	Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.	48 hours after mechanical ventilation
Primary	DD-72	Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.	72 hours after mechanical ventilation
Secondary	IL-6-24	Blook interleukin 6 24 hours after mechanical ventilation	24 hours after mechanical ventilation
Secondary	IL-6-48	Blook interleukin 6 48 hours after mechanical ventilation	48 hours after mechanical ventilation
Secondary	IL-6-72	Blook interleukin 6 72 hours after mechanical ventilation	72 hours after mechanical ventilation