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

Completed

• Conditions: Respiratory Insufficiency
• Interventions: Procedure: Adult ARF ICU patients needing BAL with HFNC

• Registration Number: NCT02523573
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Adult ARF ICU patients needing BAL with HFNC	Adult ARF ICU patients needing BAL with HFNC

Primary Outcome Measures

Name	Time	Method
increase in ventilatory support	24h	increase in ventilatory support (non-invasive positive pressure ventilation (NPPV) or endotracheal intubation (ETI)) within the first 24h following BAL

Secondary Outcome Measures

Name	Time	Method
Operator's satisfaction	15min	Physician performing the BAL procedure rated their comfort with HFNC from 0 to 10
Immediate tolerance of bronchoscopy and BAL	12h	Vital signs, dyspnea score

Trial Locations

Locations (4)

Hopital Antoine Béclère; 🇫🇷 Clamart, France

Louis Mourier Hospital; 🇫🇷 Colombes, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Hôpital Tenon; 🇫🇷 Paris, France