NCT01159106

Brief Summary

The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

July 8, 2010

Last Update Submit

July 8, 2010

Conditions

Patient/Ventilator Asynchrony

Keywords

Positive Pressure VentilationNeurally Adjusted Ventilatory AssistPatient/ventilator AsynchronyPediatric patientInfant

Outcome Measures

Primary Outcomes (1)

  • Level of asynchrony

    Number of each defined forms of asynchrony per minute during pressure support and during NAVA Six forms of asynchrony will be identified during optimal pressure support and optimal NAVA: trigger asynchrony, breath initiation asynchrony and breath termination asynchrony, demand asynchrony, inspiratory asynchrony and neuro-asynchrony

    3 hours

Interventions

Pressure Support VentilationOTHER

Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value

Neurally adjusted ventilatory assist (NAVA)OTHER

Gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube with EMG electrodes that cross the diaphragm.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Trigger asynchrony
  • Breath initiation asynchrony
  • Breath termination asynchrony
  • Patient ventilated by Servo i (Maquet Critical Care AB,Solna,Sweden)
  • Patients breathing spontaneously with no control breaths

You may not qualify if:

  • Shock
  • Agitation
  • Asynchrony caused by pain
  • Abundant tracheal secretions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (4)

  • Beck J, Tucci M, Emeriaud G, Lacroix J, Sinderby C. Prolonged neural expiratory time induced by mechanical ventilation in infants. Pediatr Res. 2004 May;55(5):747-54. doi: 10.1203/01.PDR.0000119368.21770.33. Epub 2004 Jan 22.

    PMID: 14739354BACKGROUND

  • Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b.

    PMID: 20083921BACKGROUND

  • Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.

    PMID: 19593246BACKGROUND

  • de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.

    PMID: 22481227DERIVED

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Robert M Kacmarek, PhD RRT FCCM

    Massachusetts General Hospital

    STUDY DIRECTOR

  • Pedro de la Oliva, MD PhD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

  • Jesus Villar, MD PhD

    Hospital Universitario Dr. Negrin

    PRINCIPAL INVESTIGATOR

  • Demet Suleymanci, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro De La Oliva, MD, PhD

CONTACT

poliva.hulp@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

ES(1)