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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905733
• Other study ID #: 1-2019-0009
• Status: Recruiting
• Start date: April 2019
• Est. completion date: April 2021

Study information

• Verified date: April 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Bronchus
• Foreign Bodies
• Stenosis of Trachea
• Tracheal Stenosis
• Tumor

Intervention

Device:
• Optiflow
supply of oxygen at 2 L / min/ kg through Optiflow

Locations

Country	Name	City	State
Korea, Republic of	Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	the lowest oxygen saturation	the lowest value of oxygen saturation measured percutaneously at extremity.	apnea period during the rigidbroscopic procedure/surgery
Primary	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	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.
Secondary	Arterial oxygen / carbon dioxide partial pressure		shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)