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

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Seoul National University

Status

Completed

Conditions

Hypoxia

Treatments

Device: HFNOT

Study type

Interventional

Funder types

Other

Identifiers

NCT01650974
E-1205-154-002
H-1206-074-414 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

136 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 1 or 2

  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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

136 participants in 3 patient groups

conventional oxygen therapy
No Intervention group
Description:
conventional nasal prong with FiO2 \~0.4
HFNOT
Experimental group
Description:
high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min
Treatment:
Device: HFNOT
sham-HFNOT
Sham Comparator group
Description:
same device with FiO2 \~0.4, NO high flow
Treatment:
Device: HFNOT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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