NCT00741949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 14, 2026

Status Verified

August 1, 2011

Enrollment Period

2.7 years

First QC Date

August 25, 2008

Last Update Submit

May 11, 2026

Conditions

Respiratory Insufficiency

Keywords

Respiratory failureTarget Controlled InfusionTCIPropofolNoninvasive ventilationBroncho-alveolar lavage

Outcome Measures

Primary Outcomes (1)

  • Means of oxygen saturation

    along procedure

Secondary Outcomes (3)

  • Patient satisfaction

    after procedure

  • 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

    After procedure

  • Clinical tolerance:Failure of the FOB, Minimal patient's saturation during FOB

    During procedure

Study Arms (2)

1

EXPERIMENTAL
Drug: Propofol

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PropofolDRUG

Sedation in TCI with propofol

1
PlaceboDRUG

Isotonic saline solution infusion

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Centre hospitalier Libourne

Libourne, 33505, France

Location

Related Publications (4)

  • 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.

    PMID: 17103141BACKGROUND

  • 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.

    PMID: 11605929BACKGROUND

  • Hilbert G, Clouzeau B, Nam Bui H, Vargas F. Sedation during non-invasive ventilation. Minerva Anestesiol. 2012 Jul;78(7):842-6. Epub 2012 May 11.

    PMID: 22580593RESULT

  • Clouzeau B, Bui HN, Guilhon E, Grenouillet-Delacre M, Leger MS, Saghi T, Pillot J, Filloux B, Coz S, Boyer A, Vargas F, Gruson D, Hilbert G. Fiberoptic bronchoscopy under noninvasive ventilation and propofol target-controlled infusion in hypoxemic patients. Intensive Care Med. 2011 Dec;37(12):1969-75. doi: 10.1007/s00134-011-2375-1. Epub 2011 Oct 8.

    PMID: 21983627RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Propofol

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Benjamin CLOUZEAU, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 14, 2026

Record last verified: 2011-08

Locations

FR(2)