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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00313326
Other study ID # CHU63-005
Secondary ID
Status Terminated
Phase Phase 3
First received April 11, 2006
Last updated October 7, 2008
Start date February 2005
Est. completion date September 2005

Study information

Verified date October 2008
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 66
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Adaptative Support Ventilation
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 this whatever the activity of the patient

Locations

Country Name City State
France Clermont-Ferrand University Hospital Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (2)

Petter AH, Chioléro RL, Cassina T, Chassot PG, Müller 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):1743-50. — View Citation

Sulzer CF, Chioléro 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of weaning duration Yes
Secondary Memorizing of weaning memorizing Yes
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