High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy

NCT ID: NCT01650974

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Detailed Description

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Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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conventional oxygen therapy

conventional nasal prong with FiO2 \~0.4

Group Type NO_INTERVENTION

No interventions assigned to this group

HFNOT

high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min

Group Type EXPERIMENTAL

HFNOT

Intervention Type DEVICE

high flow nasal oxygen therapy

sham-HFNOT

same device with FiO2 \~0.4, NO high flow

Group Type SHAM_COMPARATOR

HFNOT

Intervention Type DEVICE

high flow nasal oxygen therapy

Interventions

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HFNOT

high flow nasal oxygen therapy

Intervention Type DEVICE

Other Intervention Names

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high flow nasal oxygen therapy(OPTIFLOW)

Eligibility Criteria

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Inclusion Criteria

1. PaO2 \< 60 mmHg on ABGA or SpO2 \< 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
2. Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)

Exclusion Criteria

1. patients who did not agree to provide information
2. patients requiring for emergent intubation
3. patients can not wear or be already applied high flow nasal oxygen therapy
4. patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
5. patients with multiple organ failures
6. patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young-Jae Cho

Seoul National University Bundang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Jae Cho, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1206-074-414

Identifier Type: OTHER

Identifier Source: secondary_id

E-1205-154-002

Identifier Type: -

Identifier Source: org_study_id

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