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

NCT01095406 | Completed Phase 2 DMC

• 1 other identifier: CHUSJ-3011
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Weaning Phase in Children

Keywords

Weaning; closed loop; mechanical ventilation; children

Outcome Measures

Primary Outcomes (1)

• Time in acceptable breathing range

  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.

  one hour

Secondary Outcomes (1)

• Time in acceptable saturation range

  1 hour

Study Arms (2)

S1 ventilation

ACTIVE COMPARATOR

Mechanical ventilation with S1 the thrid hour of ventilation

Device: S1 ventilation

Servo i ventilation

NO INTERVENTION

1 hour ventilation in pressure support mode with Servo i

Interventions

S1 ventilation DEVICE

Ventilation with a O2 and CO2 controller

Also known as: Health Canada approval number: 155350

S1 ventilation

Eligibility Criteria

• Age: 1 Hour - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Gap between ETPCO2 and PCO2 \< 7 mmHg on last blood gas.

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (1)

Sainte-Justine Hospital - University of Montreal

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (5)

• Santschi M, Gauvin F, Hatzakis G, Lacroix J, Jouvet P. Acceptable respiratory physiologic limits for children during weaning from mechanical ventilation. Intensive Care Med. 2007 Feb;33(2):319-25. doi: 10.1007/s00134-006-0414-0. Epub 2006 Oct 25.

  PMID: 17063358 BACKGROUND

• Jouvet P, Farges C, Hatzakis G, Monir A, Lesage F, Dupic L, Brochard L, Hubert P. Weaning children from mechanical ventilation with a computer-driven system (closed-loop protocol): a pilot study. Pediatr Crit Care Med. 2007 Sep;8(5):425-32. doi: 10.1097/01.PCC.0000282157.77811.F9.

  PMID: 17693913 BACKGROUND

• Arnal JM, Wysocki M, Nafati C, Donati S, Granier I, Corno G, Durand-Gasselin J. Automatic selection of breathing pattern using adaptive support ventilation. Intensive Care Med. 2008 Jan;34(1):75-81. doi: 10.1007/s00134-007-0847-0. Epub 2007 Sep 11.

  PMID: 17846747 BACKGROUND

• Sulemanji D, Marchese A, Garbarini P, Wysocki M, Kacmarek RM. Adaptive support ventilation: an appropriate mechanical ventilation strategy for acute respiratory distress syndrome? Anesthesiology. 2009 Oct;111(4):863-70. doi: 10.1097/ALN.0b013e3181b55f8f.

  PMID: 19741490 BACKGROUND

• Jouvet P, Eddington A, Payen V, Bordessoule A, Emeriaud G, Gasco RL, Wysocki M. A pilot prospective study on closed loop controlled ventilation and oxygenation in ventilated children during the weaning phase. Crit Care. 2012 May 16;16(3):R85. doi: 10.1186/cc11343.

  PMID: 22591622 DERIVED

Study Officials

• Philippe A Jouvet, MD PhD

  Sainte-Justine Hospital - University of Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

CA (1)