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

NCT02154542 | Completed

• 1 other identifier: CHUSJ-3688
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 .

Conditions

Respiratory Failure

Keywords

Nava; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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

  within 12 hours of extubation

Secondary Outcomes (2)

• Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode

  within 12 hours of extubation

• Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal

  within 48 hours after extubation

Study Arms (2)

Experimental A

ACTIVE COMPARATOR

NAVA then standard mode

Device: Neurovent Monitor XIII

Experimental B

ACTIVE COMPARATOR

Standard mode then NAVA

Device: Neurovent Monitor XIII

Interventions

Neurovent Monitor XIII DEVICE

Also known as: Health Canada approval number: 209799

Experimental A; Experimental B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Guillaume Emeriaud, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Philippe Jouvet, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Sandrine Essouri, M.D, Ph.D.

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: June 3, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 23, 2015

Record last verified: 2015-11

Locations

CA (1)