NCT02762292: WOAW

Work of Breathing Assessment During Weaning From Mechanical Ventilation

Completed NA Last updated 23 August 2018

What this trial tests

NA trial testing Measurement of work of breathing using indirect calorimeter in Mechanical Ventilation in 20 participants. Completed in 30 June 2017.

Timeline

7 June 2016

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	St. Justine's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	7 June 2016
Primary completion	30 June 2017
Estimated completion	30 June 2017
Sites	1 location across Canada

Drugs / interventions tested

• Measurement of work of breathing using indirect calorimeter

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →

Sponsor

St. Justine's Hospital

Who can join

Adults 1 Month to 18, any sex, with Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is shared between the patient and the ventilator. During weaning from mechanical ventilation, the WOB performed by the patient must be adequate and efficient to sustain spontaneous ventilation after extubation. The monitoring of WOB during weaning might allow a better management of the weaning process. Esophageal pressure (PES) is the reference technique to measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in WOB in mechanically ventilated children during weaning from mechanical ventilation. The primary objective of this study is to assess the validity of IC method for the WOB assessment when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine extubation readiness test which generally induces an increase in WOB.

Methods This is a prospective single center study. All intubated and mechanically ventilated children \>1 months and \<18 years old, hospitalized in the pediatric intensive care unit will be eligible.

Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps: before, during and after the SBT. Then outcome of patients will be collected.

The investigators plan to study a sample of 15 patients to be representative.

Relevance to the importance of child health in Canada The investigators expect that the IC-based less invasive method will provide an accurate estimation of WOB assessment. Once this tool is validated, the interest of IC to (i) early detect an increase in WOB during mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to optimize nutritional support will be assessed in future studies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.