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Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

This study is currently recruiting participants.
Verified January 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01771341
First received: June 15, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.


Condition Intervention
Patient-ventilator Asynchronism
 Device: MAQUET SERVOi ventilator with Edi Catheter
Device: MAQUET SERVOi ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Asynchrony index (AI) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Number of asynchrony events/total respiratory rate


Secondary Outcome Measures:
  • PaO2/FiO2 ratio [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    ratio of partial pressure arterial oxygen and fraction of inspired oxygen


Estimated Enrollment: 28
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pressure support Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
Experimental: NAVA Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult > 18 yr-old
  • abdominal post-operative patient
  • able to trigger the ventilator

Exclusion Criteria:

  • infant
  • pregnancy
  • esophageal surgery
  • recent esophageal variceal bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771341

Contacts
Contact: Florent WALLET, MD +33 4 78 86 19 21 florent.wallet@chu-lyon.fr

Locations
France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France, 69310
Contact: Florent WALLET, MD     +33 4 78 86 19 21     florent.wallet@chu-lyon.fr    
Principal Investigator: Florent WALLET, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Florent WALLET, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01771341     History of Changes
Other Study ID Numbers: 2010.646
Study First Received: June 15, 2012
Last Updated: January 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
NAVA
post operative

ClinicalTrials.gov processed this record on May 19, 2013