ClinicalTrials.gg
Status unknownNCT03905733Updated Apr 5, 2019

The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients

An observational study in Foreign Bodies, Tumor and Stenosis of Trachea, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
Up to 7 Years
Sex
All
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Study summary

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on maintenance of oxygenation and removal of carbon dioxide during apnoeic period in pediatric patients undergoing general anesthesia with rigid bronchoscopy

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Conditions studied

  • Foreign Bodies
  • Tumor
  • Stenosis of Trachea
  • Bronchus
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In context

Foreign Bodies

46 studies on the registry are indexed under Foreign Bodies; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 27 observational studies indexed under Foreign Bodies.

Browse Foreign Bodies studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
  • 2. Patients aged 7 or younger who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion criteria

Exclusion Criteria:

  • 1. Patients undergoing extracorporeal membrane oxygenation (ECMO)
  • 2. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • 3. Patients with current maxillofacial trauma or basal skull fracture
  • 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • 5. Extremely low birth weight infant and premature infant less than 28 weeks gestation age
  • 6. Patients who had previously undergone rigid bronchoscopy / surgery
  • 7. If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • general anesthesia with rigid bronchoscopy

    Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy

    Device: Optiflow

Interventions

  • DeviceOptiflow

    supply of oxygen at 2 L / min/ kg through Optiflow

06

What researchers measure

Primary outcomes

  1. Hypoxia occurs the first time

    The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea

    Time frame: The time taken to reach the point at which peripheral oxygen saturation fell below 90% for the first time immediately after the onset of apnea intraoperatively.

  2. the lowest oxygen saturation

    the lowest value of oxygen saturation measured percutaneously at extremity.

    Time frame: apnea period during the rigidbroscopic procedure/surgery

  3. Occurence of hypoxic event

    Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy

    Time frame: apnea period during the rigidbroscopic procedure/surgery

Secondary outcomes

  1. End-tidal carbon dioxide partial pressure

    Time frame: end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea during intraoperative period.

  2. Arterial oxygen / carbon dioxide partial pressure

    Time frame: shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)

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Study locations

1 of 1 sites recruiting
  • Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
    Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2019; primary completion for Apr 2021, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2019
First posted
Apr 5, 2019
StartEst.
Apr 2019
Primary completionEst.
Apr 2021
CompletionEst.
Apr 2021
Last update
Apr 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03905733
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 5, 2019
Start date
Apr 2019 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Apr 5, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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