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

The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Other: Tidal volume 6 ml/kg; Other: Tidal volume 10 ml/kg

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Dr Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DD-24	Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.	24 hours after mechanical ventilation
DD-48	Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.	48 hours after mechanical ventilation
DD-72	Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.	72 hours after mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6-24	Blook interleukin 6 24 hours after mechanical ventilation	24 hours after mechanical ventilation
IL-6-48	Blook interleukin 6 48 hours after mechanical ventilation	48 hours after mechanical ventilation
IL-6-72	Blook interleukin 6 72 hours after mechanical ventilation	72 hours after mechanical ventilation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge outcome	The outcome at hospital discharge (alive or death)	Up to three months after mechanical ventilation
LOS in hospital	Length of stay (days) in hospital	Up to three months after mechanical ventilation
LOS in ICU	Length of stay (days) in ICU	Up to three months after mechanical ventilation
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
Intubation time	Time (hours) long when a patient was intubated	At extubation after mechanical ventilation

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Investigators: Study Chair: Dita Aditianingsih, Dr, Dr Cipto Mangunkusumo Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (ACTUAL): May 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Diaphragm dysfunction
• Other Study ID Numbers: DPS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared since it is belong to the hospital and patient did not consent it to be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No