Study of High Flow Nasal Cannula Oxygen for Bronchoscopy With Bronchoalveolar Lavage in ICU Patients
Optibal
High Flow Nasal Oxygen for Bronchoscopy With Bronchoalveolar Lavage in Acute Respiratory Failure Patients: the OptiBAL Study.
1 other identifier
observational
30
1 country
4
Brief Summary
Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit patients admitted for ARF requiring BAL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
Longer than P75 for all trials
4 active sites
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
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFebruary 26, 2016
February 1, 2016
3.8 years
August 13, 2015
February 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
increase in ventilatory support
increase in ventilatory support (non-invasive positive pressure ventilation (NPPV) or endotracheal intubation (ETI)) within the first 24h following BAL
24h
Secondary Outcomes (2)
Immediate tolerance of bronchoscopy and BAL
12h
Operator's satisfaction
15min
Other Outcomes (1)
Diagnosis yield of BAL
48h
Study Arms (1)
Study population
Adult ARF ICU patients needing BAL with HFNC
Interventions
bronchoalveolar lavage is performed in spontaneously breathing patients under high flow nasal cannula oxygen
Eligibility Criteria
Adult patients admitted to the Intensive Care Unit, with acute hypoxemic respiratory failure requiring bronchoalveolar lavage
You may qualify if:
- presence of acute respiratory failure: defined as respiratory rate greater than 25/min, (or greater than 20/min if use of accessory respiratory muscles was present), in patients requiring oxygen greater than or equal to 6 L/min to obtain a pulse oximetry greater than 92%
- need for bronchoalveolar lavage (decision to perform BAL was left at the physician's discretion)
You may not qualify if:
- at least one contraindication to the bronchoscopy with BAL: acute coronary syndrome within 6 weeks; neurologic failure; thrombocytopenia less than 30 000/mm3; respiratory acidosis with a pH lower than 7.30 or hypercapnia higher than 60 mmHg; pneumothorax undrained.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hôpital Louis Mourierlead
- Tenon Hospital, Pariscollaborator
- Henri Mondor University Hospitalcollaborator
- Hopital Antoine Beclerecollaborator
Study Sites (4)
Hopital Antoine Béclère
Clamart, 92, France
Louis Mourier Hospital
Colombes, 92700, France
Hopital Henri Mondor
Créteil, 94000, France
Hôpital Tenon
Paris, 75020, France
Related Publications (7)
Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
PMID: 25371400BACKGROUNDRicard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
PMID: 22531566BACKGROUNDSztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PMID: 21946925BACKGROUNDSimon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
PMID: 25529351RESULTLucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.
PMID: 22666567RESULTMaitre B, Jaber S, Maggiore SM, Bergot E, Richard JC, Bakthiari H, Housset B, Boussignac G, Brochard L. Continuous positive airway pressure during fiberoptic bronchoscopy in hypoxemic patients. A randomized double-blind study using a new device. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1063-7. doi: 10.1164/ajrccm.162.3.9910117.
PMID: 10988131RESULTLa Combe B, Messika J, Labbe V, Razazi K, Maitre B, Sztrymf B, Dreyfuss D, Fartoukh M, Ricard JD. High-flow nasal oxygen for bronchoalveolar lavage in acute respiratory failure patients. Eur Respir J. 2016 Apr;47(4):1283-6. doi: 10.1183/13993003.01883-2015. Epub 2016 Feb 11. No abstract available.
PMID: 26869676DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatrice La Combe, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Intensive Care Medicine, Assistant Head of Medico-Surgical ICU
Study Record Dates
First Submitted
August 13, 2015
First Posted
August 14, 2015
Study Start
November 1, 2011
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
February 26, 2016
Record last verified: 2016-02