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Safety and Feasibility Study of a Mechanical Ventilation Computerized Protocol: Intellivent (CloserPed)

This study has been completed.
Sponsor:
Collaborator:
Hamilton Medical AG
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01095406
First received: March 29, 2010
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

The present protocol will demonstrate the safety, feasibility and efficacy of a newly computerized protocol integrated into a ventilator: S1 ventilator (Hamilton Medical). During ventilation with S1 ventilator, the respiratory support including oxygenation and CO2 removal parameters are continuously adapted to patient respiratory status using science based rules. The present protocol is designed as a pilot evaluative study where the researchers will evaluate the safety, feasibility and efficacy of ventilating children during the weaning phase with the S1 ventilator for 5 hours, and compare to conventional ventilation.


Condition Intervention Phase
Mechanical Ventilation Weaning Phase in Children
Device: S1 ventilation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Feasibility and Efficacy of Ventilation Weaning in Children With a Computerized Protocol: a Pilot Study on S1 Ventilator With Intellivent(Hamilton Medical).

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Time in acceptable breathing range [ Time Frame: one hour ] [ Designated as safety issue: Yes ]

    Normal breathing range is defined as:

    In children age ≤ 2 years old: RR between 15 and 60 bpm and a tidal volume above 5 ml/kg of ideal body weight.

    In children > 2 years old: RR between 10 and 50 bpm and a tidal volume above 5 ml/kg of ideal body weight.



Secondary Outcome Measures:
  • Time in acceptable saturation range [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Acceptable saturation range is an SpO2 between 92% and 98%


Enrollment: 19
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S1 ventilation
Mechanical ventilation with S1 the thrid hour of ventilation
Device: S1 ventilation
Ventilation with a O2 and CO2 controller
Other Name: Health Canada approval number: 155350
No Intervention: Servo i ventilation
1 hour ventilation in pressure support mode with Servo i

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

An eligible subject will be considered for inclusion into this clinical trial if the attending physician is ready to begin weaning from mechanical ventilation and if the patient fulfils all the following inclusion criteria:

  • The attending physician thinks that the patient will be able to breathe spontaneously or the patient is already breathing spontaneously.
  • No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine or dobutamine (≤ 5 µg/kg/min)
  • Slight or no endotracheal tube gas-leakage ((Vti - Vte)/Vti ≤ 20%)
  • Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP
  • PEEP ≤ 8 cmH2O
  • FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%
  • PaCO2 < 70 mmHg on the last blood gases
  • Extubation not expected the day of inclusion
  • Gap between ETPCO2 and PCO2 < 7 mmHg on last blood gas.

Exclusion Criteria:

A patient will be excluded from this study a priori if he/she presents one or many of the following criteria:

  • The patient fails the pressure-support test (this test is described below in the section entitled "Intervention").
  • Invasive or non invasive mechanical ventilation at home or on hospital ward before PICU admission.
  • Child with a tracheotomy
  • Child with an history of mechanical ventilation > 2 months
  • Contemplate withdrawing mechanical ventilation for palliative care
  • Child with tracheobronchomalacia responsible for chronic respiratory failure
  • Child with a severe neuromuscular disease prior to admission or acquired in the PICU and unable to generate a negative pressure of at least - 20 cmH20 during inspiration.
  • Child with a "do not resuscitate order" and/or "do not reintubate order" is prescribed
  • The child is still receiving some curare
  • Cyanotic congenital heart disease with unrepaired or palliated right to left intracardiac shunt.
  • Primary pulmonary hypertension.
  • Child not expected to survive within a week, according to the attending intensivist
  • Brain death or suspected brain death
  • Morbid obesity defined by a body mass index (Actual Body Weight/T² > 40)
  • Pregnant patient
  • Parents or tutors do not agree to sign the consent form
  • S1 ventilator is not available
  • SpO2 monitoring not available (no plethysmographic curve) or not reliable
  • EtCO2 not available (no capnogram) or no reliable (see above "gap")
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095406

Locations
Canada, Quebec
Sainte-Justine Hospital - University of Montreal
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Hamilton Medical AG
Investigators
Principal Investigator: Philippe A Jouvet, MD PhD Sainte-Justine Hospital - University of Montreal
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philippe Jouvet, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01095406     History of Changes
Other Study ID Numbers: CHUSJ-3011
Study First Received: March 29, 2010
Last Updated: September 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Weaning
closed loop
mechanical ventilation
children

ClinicalTrials.gov processed this record on November 20, 2014