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

High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01650974
Acronym
HFNOT
Enrollment
136
Registered
2012-07-26
Start date
2012-07-31
Completion date
2017-11-30
Last updated
2019-04-19

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

Conditions

Hypoxia

Keywords

high flow nasal oxygen therapy, diagnostic bronchoscopy

Brief summary

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

Detailed 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.

Interventions

DEVICEHFNOT

high flow nasal oxygen therapy

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Success rate of bronchoscopy1 daySuccess is defined as completion of planned diagnostic procedure with the oxygen saturation or partial pressure of oxygen in arterial blood was similar to the level of before the procedure. Failure is defined as incompletion of planned diagnostic procedure due to sustained hypoxemia or else. Furthermore failure is defined as hypoxemia(SaO2 \<88%) was developed more than 2 times even though planned procedure was completed.
Total duration of hypoxia1 daytotal duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

Secondary

MeasureTime frameDescription
frequency of hypoxia1 dayfrequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
switch to oxygen therapy method1 dayIncrease oxygen apply or change of oxygen therapy method to high flow system.
change of respiratory symptoms1 dayscoring of dyspnea symptoms, patients comfort.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026