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

April 3, 2019 updated by: Yonsei University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
general anesthesia with rigid bronchoscopy
Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy
Device: Optiflow
supply of oxygen at 2 L / min/ kg through Optiflow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the lowest oxygen saturation
Time Frame: apnea period during the rigidbroscopic procedure/surgery
the lowest value of oxygen saturation measured percutaneously at extremity.
apnea period during the rigidbroscopic procedure/surgery
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 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.
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
apnea period during the rigidbroscopic procedure/surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
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)
shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-2019-0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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