Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Prospective Randomised Study on the Safety of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01870765

Enrollment

Registered

2013-06-06

Start date

2013-07-31

Completion date

2014-02-28

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

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.

Interventions

DEVICEnon-invasive ventilation

non-invasive ventilation via face mask

DEVICEhigh-flow oxygen

high-flow oxygen via nasal cannula

PROCEDUREfiberoptic bronchoscopy

fiberoptic bronchoscopy including broncho-alveolar lavage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.	during fiberoptic bronchoscopy

Secondary

Measure	Time frame
Changes in blood gases after the completion of fiberoptic bronchoscopy.	1 hour after the completion of bronchoscopy

Other

Measure	Time frame
Requirement of intubation after the completion of bronchoscopy.	8 hours after the completion of bronchoscopy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026