Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Completed
CT.gov ID
NCT03027713
Collaborator
(none)
40
2
48
Study Details
Study Description
Brief Summary
The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Jun 1, 2013
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: NAVA group with a specific catheter The patients were allocated in the NAVA weaning protocol group |
Procedure: weaning protocol
The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
|
| Other: PSV group without a specific catheter The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group |
Procedure: weaning protocol
The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
|
Outcome Measures
Primary Outcome Measures
- Diaphragmatic electromyographic activity description [1 hour]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.
Exclusion Criteria:
- Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
- Principal Investigator: Mar Garzando Civera, M.D., Ph.D., Fundación para la investigación del Hospital Clínico Universitario de Valencia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
F Javier Belda,
Prof. Dr.,
Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT03027713
Other Study ID Numbers:
- dawNAVA
First Posted:
Jan 23, 2017
Last Update Posted:
Jan 23, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by F Javier Belda,
Prof. Dr.,
Fundación para la Investigación del Hospital Clínico de Valencia