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Completed

NCT Number: NCT03892408

High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

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Key information

Conditions

Foreign Bodies Bronchial Diseases Bronchial Neoplasms Bronchus Tumour Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stenosis Trachea Thoracic Neoplasms Tracheal Diseases Tracheal Stenosis Tumor Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion criteria

  • 1. Patients with dementia or cognitive impairment
  • 2. pregnant women
  • 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
  • 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • 5. Patients with current maxillofacial trauma or basal skull fracture
  • 6. Patients who had previously undergone rigid bronchoscopy / surgery
  • 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Treatment and study plan

Optiflow ™

Device

supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.

Primary outcomes

  1. the lowest oxygen saturation

    Time frame: apnea period during the rigidbroscopic procedure/surgery

    the lowest value of oxygen saturation measured percutaneously at extremity.

Secondary outcomes

  1. Hypoxia occurs the first time

    Time frame: intraoperative (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)

  2. End-tidal carbon dioxide partial pressure

    Time frame: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)

  3. Arterial oxygen / carbon dioxide partial pressure

    Time frame: shortly before start of apnea (within 30 seconds)

  4. Arterial oxygen / carbon dioxide partial pressure

    Time frame: shortly after end of apnea (within 30 seconds)

  5. hypoxemia related surgical interruptions

    Time frame: 4) hypoxemia related surgical interruptions during apneic period

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2019
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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