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Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF (SEDA-FIBRO)

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Propofol
Placebo
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Insufficiency focused on measuring Respiratory failure, Target Controlled Infusion, TCI, Propofol, Noninvasive ventilation, Broncho-alveolar lavage

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute respiratory failure defined by clinical signs of respiratory failure (polypnea, use of accessory respiratory muscle) and a PaO2/FiO2 ratio < 250
  • Need for a diagnosis FOB with BAL
  • Informed consent signed

Exclusion Criteria:

  • Contraindication of NIV
  • FOB with bronchial biopsies
  • Acute coronary syndrome
  • Thrombopenia < 30.000 / mm3 despite platelets transfusion
  • Coagulation disorders
  • PaO2/FiO2 ratio < 80 under NIV
  • Persistent respiratory acidosis under NIV (pH < 7,32)
  • Propofol allergy
  • Xylocaïne allergy
  • Pregnancy
  • Age < 18 years or > 90 years
  • Weight > 150 kg or < 30 kg
  • Inclusion in another clinical protocol

Sites / Locations

  • University Hospital Bordeaux, Groupe Hospitalier Pellegrin
  • Centre hospitalier Libourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Means of oxygen saturation

Secondary Outcome Measures

Patient satisfaction
Facilitation of the procedure for the fibroscopist: Length of the procedure Volume of BAL aspiration in percentage of aliquot injection Quality of the BAL on cytologic examination
Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB

Full Information

First Posted
August 25, 2008
Last Updated
August 25, 2011
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00741949
Brief Title
Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF
Acronym
SEDA-FIBRO
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory failure, Target Controlled Infusion, TCI, Propofol, Noninvasive ventilation, Broncho-alveolar lavage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Sedation in TCI with propofol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Isotonic saline solution infusion
Primary Outcome Measure Information:
Title
Means of oxygen saturation
Time Frame
along procedure
Secondary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
after procedure
Title
Facilitation of the procedure for the fibroscopist: Length of the procedure Volume of BAL aspiration in percentage of aliquot injection Quality of the BAL on cytologic examination
Time Frame
After procedure
Title
Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute respiratory failure defined by clinical signs of respiratory failure (polypnea, use of accessory respiratory muscle) and a PaO2/FiO2 ratio < 250 Need for a diagnosis FOB with BAL Informed consent signed Exclusion Criteria: Contraindication of NIV FOB with bronchial biopsies Acute coronary syndrome Thrombopenia < 30.000 / mm3 despite platelets transfusion Coagulation disorders PaO2/FiO2 ratio < 80 under NIV Persistent respiratory acidosis under NIV (pH < 7,32) Propofol allergy Xylocaïne allergy Pregnancy Age < 18 years or > 90 years Weight > 150 kg or < 30 kg Inclusion in another clinical protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin CLOUZEAU, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre hospitalier Libourne
City
Libourne
ZIP/Postal Code
33505
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17103141
Citation
Constantin JM, Schneider E, Cayot-Constantin S, Guerin R, Bannier F, Futier E, Bazin JE. Remifentanil-based sedation to treat noninvasive ventilation failure: a preliminary study. Intensive Care Med. 2007 Jan;33(1):82-7. doi: 10.1007/s00134-006-0447-4. Epub 2006 Nov 14.
Results Reference
background
PubMed Identifier
11605929
Citation
Nieuwenhuijs D, Sarton E, Teppema LJ, Kruyt E, Olievier I, van Kleef J, Dahan A. Respiratory sites of action of propofol: absence of depression of peripheral chemoreflex loop by low-dose propofol. Anesthesiology. 2001 Oct;95(4):889-95. doi: 10.1097/00000542-200110000-00017.
Results Reference
background

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Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF

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