NCT00603174

Brief Summary

The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in infants by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for 12 hours, and to compare it to conventional ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1.7 years

First QC Date

November 21, 2007

Last Update Submit

September 18, 2012

Conditions

Respiratory Failure

Keywords

NAVAmechanical ventilationinfantspediatric intensive careinfant

Outcome Measures

Primary Outcomes (1)

  • patient-ventilator synchrony

    Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))

    up to 28 days

Secondary Outcomes (4)

  • Tolerance

    up to 28 days

  • Number of times back-up rate started (per hour) in NAVA mode

    up to 28 days

  • Number of PEEP or NAVA level adjustments in NAVA mode

    up to 28 days

  • Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi

    up to 28 days

Study Arms (1)

A

EXPERIMENTAL

Intubated and mechanically ventilated infants with respiratory failure (age \< 1 year old). see inclusion-exclusion criteria.

Device: neurally adjusted ventilatory assist (NAVA)

Interventions

neurally adjusted ventilatory assist (NAVA)DEVICE

Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.

A

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Intubated and mechanically ventilated infant with respiratory failure \< 1 year old)
  • Breathing spontaneously, as defined by the ability to trigger the ventilator
  • The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: pressure plateau \< 22 cm H2O (above PEEP) and PEEP ≤ 6 cm H2O.

You may not qualify if:

  • Pneumothorax
  • Degenerative neuromuscular disease
  • Bleeding disorders
  • Cardiovascular instability defined by vasopressors infusion (dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, dobutamine, vasopressin)
  • Cyanotic congenital cardiovascular disease
  • Phrenic nerve damage/diaphragm paralysis
  • Esophageal perforation
  • Use of high frequency oscillatory or jet ventilation
  • Contraindication to changing naso gastric tube
  • Infant is deemed "too unstable" by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center -CHU Sainte Justine - University of Montreal

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

  • Sinderby C, Beck J, Spahija J, de Marchie M, Lacroix J, Navalesi P, Slutsky AS. Inspiratory muscle unloading by neurally adjusted ventilatory assist during maximal inspiratory efforts in healthy subjects. Chest. 2007 Mar;131(3):711-717. doi: 10.1378/chest.06-1909.

    PMID: 17356084BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Philippe A Jouvet, MD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Jennifer Beck, PhD

    SunnyBrook Health Sciences Centre - Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 21, 2007

First Posted

January 28, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

CA(1)