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

NCT03905733 | Unknown

• 1 other identifier: 1-2019-0009
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Foreign Bodies; Tumor; Stenosis of Trachea; Bronchus

Outcome Measures

Primary Outcomes (3)

• 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.

• the lowest oxygen saturation

  the lowest value of oxygen saturation measured percutaneously at extremity.

  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

  apnea period during the rigidbroscopic procedure/surgery

Secondary Outcomes (2)

• 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)

Study Arms (1)

general anesthesia with rigid bronchoscopy

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

Device: Optiflow

Interventions

Optiflow DEVICE

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

general anesthesia with rigid bronchoscopy

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Foreign Bodies; Neoplasms; Tracheal Stenosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Tracheal Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

KR (1)