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Study to Improve Treatments and Follow-up of Children Who Need Respiratory Support (Edi-PTP)

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neurovent Monitor XIII
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Nava, Mechanical ventilation

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Up to 18 years
  • Child on invasive mechanical ventilation for which the withdrawal phase was determined by the clinician in charge of the patient
  • Consent obtained

Exclusion Criteria:

  • Post conceptional age < 37 weeks
  • Contraindication to changing or insertion of nasogastric tube (esophageal malformation, gastrointestinal bleeding, esophageal varices)
  • Curarised patient

Sites / Locations

  • St. Justine's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Experimental A

Experimental B

Arm Description

NAVA then standard mode

Standard mode then NAVA

Outcomes

Primary Outcome Measures

The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning

Secondary Outcome Measures

Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode
Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal

Full Information

First Posted
May 13, 2014
Last Updated
November 20, 2015
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02154542
Brief Title
Study to Improve Treatments and Follow-up of Children Who Need Respiratory Support
Acronym
Edi-PTP
Official Title
Validation of the Measurement of Respiratory Work Using Diaphragm Electrical Activity in Infant and Children During Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the duration of ventilation, mortality, length of ICU stay and health costs. The practitioner should ask the benefit of the continuation of this IV daily and adapting it, to limit complications. The evaluation of the work of breathing is a key element in understanding the pathophysiology of respiratory distress but is also a key element in improving the management of ventilatory support and the adjustment of ventilatory parameters . It has been shown that there is an increased work of breathing in all children admitted in ICU for clinical acute respiratory distress that is significantly reduced by ventilatory support. There is probably a relationship that should be proportional between the work of breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the electrical activity of the diaphragm ( Edi ) . The validation of this correlation PTP / Edi has a direct impact on the monitoring of ventilated patients with the ability to monitor the physiological factor while maintaining a classical treatment of children by simply monitoring Edi without additional invasive device .
Detailed Description
It is very important that the respirators detect the child's breathing efforts. This makes it possible to reduce the pressure used by the respirator to push air into the child's lungs, to improve oxygen distribution throughout the child's body and reduce the level of sedation Typical systems do not really detect changes in breathing efforts, but rather volumes of exhaled air. Therefore, the respirator is not always synchronized with patient's respiration and there may be a delay between breathing cycles and the ventilator's, which leads to an increase in his respiratory effort. Assessing respiratory work is a key element in improving the management of ventilatory support and the adaptation of ventilatory parameters. At this time, routinely used measurements do not include quantitative measurement of the respiratory work, as it requires the installation of probes with pressure heads. There is new technology known as Neurally Adjusted Ventilatory Assist (NAVA) that employs a probe inserted into the stomach that detects the electrical activity of the diaphragm (primary breathing muscle).The probe is connected to the respirator and triggers respiratory assistance through diaphragm electrical activity, thereby ensuring respiratory assistance that is adapted to the child's needs. This artificial ventilatory mode has already been widely used during invasive ventilation in adults and for short periods of time in infants, children and premature newborn. Health Canada has authorized the use of the NAVA ventilatory mode within the context of this study. The aim of this study is to assess whether there is a relation between the electrical activity of the diaphragm and respiratory work. This will enable the use of diaphragm activity that can be recorded daily at the child's bedside as an element of respiratory monitoring and allow early detection of dangerously high or low respiratory levels. The study plans to recruit 20 patients at the CHU Sainte-Justine, which is the only hospital taking part in the study. The investigators will replace the probe placed in the stomach of any child under artificial ventilation with the study probe. The probe is changed regularly as part of routine care. The study probe is equipped with microelectrodes to measure diaphragm activity as well as a very fine balloon to measure pressure. The patient's diaphragm activity and respiratory work will then be assessed over a 2-hour period under two different ventilatory conditions (the NAVA mode and the conventional mode) in random order. The investigators will perform a random draw to determine the initial ventilator mode. The two periods, each lasting 60 minutes, will proceed as follows: The conventional ventilation period: the ventilation parameters are adjusted by the care team based on the practices in effect within the department; the researcher will not intervene. The NAVA mode period: the initial settings are determined to target support that is similar to that prescribed by the care team and after that are adjusted based on NAVA clinical protocol in effect within the department During the final 30 minutes of each period, a computer will record ventilation parameters, diaphragm activity and respiratory effort. These data will be recorded using a simple connection to the ventilator and no change in the patient's equipment will be required. If the study naso-gastric tube is still in place at the time of extubation, 3 additional measurements (10 minutes each) will be taken to assess changes in diaphragm activity and respiratory work around extubation: An initial recording during the hour before extubation; A second one at extubation; and; A third one two hours after extubation. The investigators will follow patient progress for another 48 hours after extubation. Data will be collected in the child's medical record for the purposes of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Nava, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental A
Arm Type
Active Comparator
Arm Description
NAVA then standard mode
Arm Title
Experimental B
Arm Type
Active Comparator
Arm Description
Standard mode then NAVA
Intervention Type
Device
Intervention Name(s)
Neurovent Monitor XIII
Other Intervention Name(s)
Health Canada approval number: 209799
Primary Outcome Measure Information:
Title
The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning
Time Frame
within 12 hours of extubation
Secondary Outcome Measure Information:
Title
Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode
Time Frame
within 12 hours of extubation
Title
Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal
Time Frame
within 48 hours after extubation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Up to 18 years Child on invasive mechanical ventilation for which the withdrawal phase was determined by the clinician in charge of the patient Consent obtained Exclusion Criteria: Post conceptional age < 37 weeks Contraindication to changing or insertion of nasogastric tube (esophageal malformation, gastrointestinal bleeding, esophageal varices) Curarised patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Emeriaud, MD, PhD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Jouvet, MD, PhD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandrine Essouri, M.D, Ph.D.
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Justine's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

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Study to Improve Treatments and Follow-up of Children Who Need Respiratory Support

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