Foreign BodiesNCT03905733
The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients
An observational study of Foreign Bodies and Tumor, run by Yonsei University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Foreign Bodies, Tumor, Stenosis of Trachea
- What is being tested?
- Optiflow
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2019to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
Seoul
Chang Young Lee, MD, 82-10-2720-7399, CYLEECS@yuhs.ac
About this study
Official title: The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients: A Prospective Observational Pilot Study
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
- Conditions
- Foreign Bodies, Tumor, Stenosis of Trachea, Bronchus
- Being tested
- Optiflow
- Medical subject headings
- Foreign Bodies, Neoplasms, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiflowDevice
supply of oxygen at 2 L / min/ kg through Optiflow
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia with rigid bronchoscopy | Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy Receives: Device: Optiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
the lowest oxygen saturation
the lowest value of oxygen saturation measured percutaneously at extremity.
Measured: apnea period during the rigidbroscopic procedure/surgery
Occurence of hypoxic event
Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy
Measured: apnea period during the rigidbroscopic procedure/surgery
Secondary outcomes (2)
End-tidal carbon dioxide partial pressure
Measured: end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea during intraoperative period.
Arterial oxygen / carbon dioxide partial pressure
Measured: shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign BodiesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905733
- Sponsor's protocol ID
- 1-2019-0009
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03905733
- Acronym / sponsor ID
- 1-2019-0009
- Conditions
- Foreign Bodies, Tumor, Stenosis of Trachea, Bronchus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general anesthesia with rigid bronchoscopy | – | Device: OptiflowPatients 7 years or younger who undergo general anesthesia with rigid bronchoscopy |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optiflowsupply of oxygen at 2 L / min/ kg through Optiflow | Device | general anesthesia with rigid bronchoscopy |
Primary outcome
Hypoxia occurs the first time
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.
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
the lowest oxygen saturation
Time frame: apnea period during the rigidbroscopic procedure/surgery
the lowest value of oxygen saturation measured percutaneously at extremity.
Occurence of hypoxic event
Time frame: apnea period during the rigidbroscopic procedure/surgery
Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy
2 secondary outcomes
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.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foreign Bodies and Tumor, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia occurs the first time (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.