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

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ClinicalTrials.gov Identifier: NCT02523573
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : February 26, 2016
Sponsor:
Collaborators:
Tenon Hospital, Paris
Henri Mondor University Hospital
Hopital Antoine Beclere
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

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.

Condition or disease Intervention/treatment
Respiratory Insufficiency Procedure: Adult ARF ICU patients needing BAL with HFNC

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High Flow Nasal Oxygen for Bronchoscopy With Bronchoalveolar Lavage in Acute Respiratory Failure Patients: the OptiBAL Study.
Study Start Date : November 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study population
Adult ARF ICU patients needing BAL with HFNC
Procedure: Adult ARF ICU patients needing BAL with HFNC
bronchoalveolar lavage is performed in spontaneously breathing patients under high flow nasal cannula oxygen




Primary Outcome Measures :
  1. increase in ventilatory support [ Time Frame: 24h ]
    increase in ventilatory support (non-invasive positive pressure ventilation (NPPV) or endotracheal intubation (ETI)) within the first 24h following BAL


Secondary Outcome Measures :
  1. Immediate tolerance of bronchoscopy and BAL [ Time Frame: 12h ]
    Vital signs, dyspnea score

  2. Operator's satisfaction [ Time Frame: 15min ]
    Physician performing the BAL procedure rated their comfort with HFNC from 0 to 10


Other Outcome Measures:
  1. Diagnosis yield of BAL [ Time Frame: 48h ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to the Intensive Care Unit, with acute hypoxemic respiratory failure requiring bronchoalveolar lavage
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523573


Locations
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France
Hopital Antoine Béclère
Clamart, France, 92
Louis Mourier Hospital
Colombes, France, 92700
Hopital Henri Mondor
Creteil, France, 94000
Hôpital Tenon
Paris, France, 75020
Sponsors and Collaborators
Hôpital Louis Mourier
Tenon Hospital, Paris
Henri Mondor University Hospital
Hopital Antoine Beclere
Investigators
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Principal Investigator: Beatrice La Combe, MD Assistance Publique - Hôpitaux de Paris
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, Assistant Head of Medico-Surgical ICU, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT02523573    
Other Study ID Numbers: HLM_JDR4
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases