Clinical trial NCT02523573: Study of High Flow Nasal Cannula Oxygen for Bronchoscopy With Bronchoalveolar Lavage in ICU Patients
Official title: High Flow Nasal Oxygen for Bronchoscopy With Bronchoalveolar Lavage in Acute Respiratory Failure Patients: the OptiBAL Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
Collaborators: name: Tenon Hospital, Paris
name: Henri Mondor University Hospital
name: Hopital Antoine Beclere
First posted: 2015-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to the Intensive Care Unit, with acute hypoxemic respiratory failure requiring bronchoalveolar lavage

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.

Detailed description: Prospective, observational, multicenter study in ARF patients (minimal pulse oximetry -SpO2- of 92% with an minimal oxygen flow of 6 L/min , respiratory rate \> 25/min (20/min if use of accessory respiratory muscles) with a compatible etiology. Primary outcome measure is increase in ventilatory support (non-invasive positive pressure ventilation (NPPV) or endotracheal intubation (ETI)) within the first 24h following BAL.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: increase in ventilatory support
timeFrame: 24h
Secondary outcomes:
measure: Immediate tolerance of bronchoscopy and BAL
timeFrame: 12h
measure: Operator's satisfaction
timeFrame: 15min
Other outcomes:
measure: Diagnosis yield of BAL
timeFrame: 48h
Locations:
city: Clamart
country: France
facility: Hopital Antoine Béclère
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Beatrice La Combe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
citation: Sztrymf 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.
citation: Simon 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.
citation: Lucangelo 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.
citation: Maitre 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.
citation: La 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.