NCT01650974

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 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

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

5.3 years

First QC Date

July 24, 2012

Last Update Submit

April 17, 2019

Conditions

Hypoxia

Keywords

high flow nasal oxygen therapydiagnostic bronchoscopy

Outcome Measures

Primary Outcomes (2)

  • Success rate of bronchoscopy

    Success 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.

    1 day

  • Total duration of hypoxia

    total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.

    1 day

Secondary Outcomes (3)

  • frequency of hypoxia

    1 day

  • switch to oxygen therapy method

    1 day

  • change of respiratory symptoms

    1 day

Study Arms (3)

conventional oxygen therapy

NO INTERVENTION

conventional nasal prong with FiO2 \~0.4

HFNOT

EXPERIMENTAL

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

Device: HFNOT

sham-HFNOT

SHAM COMPARATOR

same device with FiO2 \~0.4, NO high flow

Device: HFNOT

Interventions

HFNOTDEVICE

high flow nasal oxygen therapy

Also known as: high flow nasal oxygen therapy(OPTIFLOW)
HFNOTsham-HFNOT

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Young-Jae Cho, MD, MPH

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Bundang Hospital

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

KR(1)