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

NCT05370248 | Unknown

• 1 other identifier: DPS1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

Mechanical ventilation; Diaphragm dysfunction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• IL-6-24

  24 hours after mechanical ventilation

• IL-6-48

  48 hours after mechanical ventilation

• IL-6-72

  72 hours after mechanical ventilation

Other Outcomes (5)

• Discharge outcome

  Up to three months after mechanical ventilation

• LOS in hospital

  Up to three months after mechanical ventilation

• LOS in ICU

  Up to three months after mechanical ventilation

Study Arms (2)

The six

EXPERIMENTAL

The group who received tidal volume of 6 ml/kg from mechanical ventilation

Other: Tidal volume 6 ml/kg

The ten

ACTIVE COMPARATOR

The group who received tidal volume of 10 ml/kg from mechanical ventilation

Other: Tidal volume 10 ml/kg

Interventions

Tidal volume 6 ml/kg OTHER

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 six

Tidal volume 10 ml/kg OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age 18 years old
• Critically ill patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Dr Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (8)

• 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.

  PMID: 26271686 BACKGROUND

• 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.

  PMID: 16231069 BACKGROUND

• 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.

  PMID: 27626833 BACKGROUND

• 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.

  PMID: 30144420 BACKGROUND

• 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.

  PMID: 28887062 BACKGROUND

• 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.

  PMID: 23641946 BACKGROUND

• 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.

  PMID: 27620292 BACKGROUND

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

  PMID: 7875282 BACKGROUND

MeSH Terms

Interventions

Tidal Volume

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dita Aditianingsih, Dr

  Dr Cipto Mangunkusumo Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to which group they belong and they have given consent to that. 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant In-Training, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 11, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)