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NCT Number: NCT02523573

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

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Antoine Béclère, Clamart, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adult ARF ICU patients needing BAL with HFNC

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Diagnosis yield of BAL

    Time frame: 48h

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Collaborators

  • Henri Mondor University Hospital
  • Hopital Antoine Beclere
  • Tenon Hospital, Paris

Registry information

Official study title

High Flow Nasal Oxygen for Bronchoscopy With Bronchoalveolar Lavage in Acute Respiratory Failure Patients: the OptiBAL Study.

Acronym: Optibal

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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