Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF (SEDA-FIBRO)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 25, 2008 | ||||||||
| Last Updated Date | August 25, 2011 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Means of oxygen saturation [ Time Frame: along procedure ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00741949 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF | ||||||||
| Official Title ICMJE | Fiberoptic Bronchoscopy With Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol Target Controled Infusion in Patient With Acute Hypoxemic Respiratory Failure. A Randomized Controlled Study : SEDA-FIBRO. | ||||||||
| Brief Summary | Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases, more particularly in infectious pneumonia. In patients with severe acute hypoxemic respiratory failure, FOB may be contra-indicated until the patient is intubated and control of its oxygenation obtained. In the literature several authors showed that performing FOB under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic respiratory failure. Nevertheless this procedure remains uncomfortable in most patients with respiratory failure. In addition, patient's agitation may lead to desaturation, and compromise the realization of FOB. |
||||||||
| Detailed Description | In acute hypoxemic respiratory failure, FOB with BAL can be life threatening because of a deep oxygen desaturation. Performing FOB under NIV has been shown efficient to prevent episodes of desaturation. Several modes of ventilation have been tried ; Continuous Positive Airways Pressure and Pressure Support Ventilation both showed superiority when compared to oxygen supplementation alone. The recent French consensus on NIV recommends performing FOB under NIV in hypoxemic conditions. Efficacy of NIV can be altered by patient agitation or asynchronism with the ventilator. Though, some authors have proposed the use of sedative agents like remifentanyl during NIV. To our knowledge, none study has evaluated the beneficial effect of sedation during a FOB with BAL under NIV. Propofol is an anesthetic agent which can be administered in TCI, to maintain a constant concentration in the target cerebral compartment. Propofol is widely used in different types of anesthesia. Using the same concept, authors have reported its use in sedation, with smaller target concentrations. TCI sedation with propofol preserves patient's spontaneous ventilation, and does not alter hemodynamic parameters. Our hypothesis is that sédation by TCI with propofol will lead to best oxygen saturation than without this intervention in patients with acute hypoxemic respiratory failure and undergoing FOB with BAL under NIV. Thus, we designed a randomized controlled study. Eligible patients will be randomized in two groups. In the treatment group, patients will receive sedation with propofol during the procedure of FOB under NIV. In the other group, patients will receive a placebo during the same procedure. Patients and fibroscopist won't be aware of the randomization group |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Respiratory Insufficiency | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 46 | ||||||||
| Completion Date | June 2011 | ||||||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00741949 | ||||||||
| Other Study ID Numbers ICMJE | CHUBX 2007/29 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | August 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||