NCT01870765

Brief Summary

Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

May 30, 2013

Last Update Submit

November 10, 2020

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.

    during fiberoptic bronchoscopy

Secondary Outcomes (1)

  • Changes in blood gases after the completion of fiberoptic bronchoscopy.

    1 hour after the completion of bronchoscopy

Other Outcomes (1)

  • Requirement of intubation after the completion of bronchoscopy.

    8 hours after the completion of bronchoscopy

Study Arms (2)

non-invasive ventilation

ACTIVE COMPARATOR

Performance of bronchoscopy during non-invasive ventilation.

Device: non-invasive ventilationProcedure: fiberoptic bronchoscopy

high-flow oxygen

EXPERIMENTAL

Performance of bronchoscopy during high-flow oxygen therapy.

Device: high-flow oxygenProcedure: fiberoptic bronchoscopy

Interventions

non-invasive ventilationDEVICE

non-invasive ventilation via face mask

non-invasive ventilation
high-flow oxygenDEVICE

high-flow oxygen via nasal cannula

high-flow oxygen
fiberoptic bronchoscopyPROCEDURE

fiberoptic bronchoscopy including broncho-alveolar lavage

high-flow oxygennon-invasive ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients treated in an intensive care unit
  • indication for bronchoscopy and broncho-alveolar lavage
  • presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure

You may not qualify if:

  • patients already on invasive ventilation
  • indication for intubation
  • blocked nasopharynx
  • contraindications for non-invasive ventilation or high-flow oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine

Hamburg, 20246, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25529351RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Stefan Kluge

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 6, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(1)