Study of High Flow Nasal Cannula Oxygen for Bronchoscopy With Bronchoalveolar Lavage in ICU Patients

NCT ID: NCT02523573

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Respiratory Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

Adult ARF ICU patients needing BAL with HFNC

Adult ARF ICU patients needing BAL with HFNC

Intervention Type PROCEDURE

bronchoalveolar lavage is performed in spontaneously breathing patients under high flow nasal cannula oxygen

Interventions

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Adult ARF ICU patients needing BAL with HFNC

bronchoalveolar lavage is performed in spontaneously breathing patients under high flow nasal cannula oxygen

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tenon Hospital, Paris

OTHER

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role collaborator

Hopital Antoine Beclere

OTHER

Sponsor Role collaborator

Hôpital Louis Mourier

OTHER

Sponsor Role lead

Responsible Party

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Prof Jean-Damien RICARD

Professor of Intensive Care Medicine, Assistant Head of Medico-Surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beatrice La Combe, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Antoine Béclère

Clamart, , France

Site Status

Louis Mourier Hospital

Colombes, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25371400 (View on PubMed)

Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.

Reference Type BACKGROUND
PMID: 22531566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21946925 (View on PubMed)

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.

Reference Type RESULT
PMID: 25529351 (View on PubMed)

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.

Reference Type RESULT
PMID: 22666567 (View on PubMed)

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.

Reference Type RESULT
PMID: 10988131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26869676 (View on PubMed)

Other Identifiers

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HLM_JDR4

Identifier Type: -

Identifier Source: org_study_id

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