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

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: Unknown
• Conditions: Tumor; Foreign Bodies; Stenosis of Trachea; Bronchus
• Intervention / Treatment: Device: Optiflow

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
    • Contact: Chang Young Lee, MD; Phone Number: 82-10-2720-7399; Email: CYLEECS@yuhs.ac

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
the lowest oxygen saturation	the lowest value of oxygen saturation measured percutaneously at extremity.	apnea period during the rigidbroscopic procedure/surgery
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	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	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

Outcome Measure	Time Frame
End-tidal carbon dioxide partial pressure	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	shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Wounds and Injuries; Tracheal Diseases; Foreign Bodies; Tracheal Stenosis
• Other Study ID 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