- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00313326
Comparative Study of Duration of Respiratory Weaning Between Adaptive Support Ventilation and Succession of Controlled Ventilation Then Spontaneous Ventilation for Patients After Surgery
October 7, 2008 updated by: University Hospital, Clermont-Ferrand
This is a comparative study of duration of respiratory weaning between adaptive support ventilation and succession of controlled ventilation then spontaneous ventilation for patients after surgery.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
General anaesthesia is marked by the passage of a stage of controlled ventilation where the patient does not carry out any respiratory work and the stage of spontaneous ventilation, which precedes extubation.
Adaptive support ventilation (ASV) is a new protocol of weaning of the tracheal prosthesis after surgery which maintains a preset ventilation by an operator and the activity of the patient.
At each breath, a microprocessor allows an optimization of volume and frequency by an adjustment of the inspiratory pressure and frequency.
ASV was already validated for fast tracheal extubation after cardiac surgery.
Our study proposes to compare the duration of intubation between this mode of weaning and with the traditional way (controlled ventilation then spontaneous ventilation) for faster surgery.
The purpose of the study is to check the interest of ASV to limit the duration of intubation compared to the traditional protocol in this kind of intervention.
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Clermont-Ferrand, France, 63000
- Clermont-Ferrand University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Surgery < 2 hours
- Anesthesia with thiopental, midazolam, sufentanil and suprane
Exclusion Criteria:
- Patients ASA III or IV (classification of American Sociéty of Anesthésiologist)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of weaning
Time Frame: duration
|
duration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Memorizing of weaning
Time Frame: memorizing
|
memorizing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eric Schneider, Doctor, University Hospital, Clermont-Ferrand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Petter AH, Chiolero RL, Cassina T, Chassot PG, Muller XM, Revelly JP. Automatic "respirator/weaning" with adaptive support ventilation: the effect on duration of endotracheal intubation and patient management. Anesth Analg. 2003 Dec;97(6):1743-1750. doi: 10.1213/01.ANE.0000086728.36285.BE.
- Sulzer CF, Chiolero R, Chassot PG, Mueller XM, Revelly JP. Adaptive support ventilation for fast tracheal extubation after cardiac surgery: a randomized controlled study. Anesthesiology. 2001 Dec;95(6):1339-45. doi: 10.1097/00000542-200112000-00010.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
April 11, 2006
First Submitted That Met QC Criteria
April 11, 2006
First Posted (Estimate)
April 12, 2006
Study Record Updates
Last Update Posted (Estimate)
October 8, 2008
Last Update Submitted That Met QC Criteria
October 7, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU63-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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