Safety and Feasibility Study of a Mechanical Ventilation Computerized Protocol: Intellivent (CloserPed)
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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). |
- 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.
- 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 |
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| Canada, Quebec | |
| Sainte-Justine Hospital - University of Montreal | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Principal Investigator: | Philippe A Jouvet, MD PhD | Sainte-Justine Hospital - University of Montreal |
More Information
Publications:
| 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 May 22, 2013