Ventilator WeaningPhase 3NCT00313326
Comparative Study of Duration of Respiratory Weaning Between Adaptive Support Ventilation and Succession of Controlled Ventilation Then Spontaneous Ventilation for Patients After Surgery
A Phase 3 study testing Adaptative Support Ventilation in people with Ventilator Weaning, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- Adaptative Support Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery < 2 hours
- Anesthesia with thiopental, midazolam, sufentanil and suprane
Who cannot join
- Patients ASA III or IV (classification of American Sociéty of Anesthésiologist)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ventilator Weaning
- Being tested
- Adaptative Support Ventilation
- Keywords
- Adaptive Support ventilation, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptative Support VentilationProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of weaning
Measured: duration
Secondary outcomes (1)
Memorizing of weaning
Measured: memorizing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startFeb 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Eric Schneider, Doctor, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313326
- Sponsor's protocol ID
- CHU63-005
- Status last verified
- Oct 2008
- First submitted
- 11 Apr 2006
- Last updated
- 8 Oct 2008
- Results posted
- No
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.
PubMed 14633553Sulzer 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.
PubMed 11748389
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Duration of Respiratory Weaning Between Adaptive Support Ventilation and Succession of Controlled Ventilation Then Spontaneous Ventilation for Patients After Surgery
- ClinicalTrials.gov ID
- NCT00313326
- Acronym / sponsor ID
- CHU63-005
- Conditions
- Ventilator Weaning
- Keywords
- Adaptive Support ventilation, Weaning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery < 2 hours
- Anesthesia with thiopental, midazolam, sufentanil and suprane
Key exclusion criteria (1 listed)
- Patients ASA III or IV (classification of American Sociéty of Anesthésiologist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptative Support VentilationAdaptive 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 | Procedure or surgery | – |
Primary outcome
Duration of weaning
Time frame: duration
1 secondary outcome
Memorizing of weaning
Time frame: memorizing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Background: PubMed 14633553Petter 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.
- Background: PubMed 11748389Sulzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Schneider, Doctor principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adaptative Support Ventilation in people with Ventilator Weaning, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of weaning (time frame: duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313326, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2008.