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Trial record 28 of 579 for:    CARBON DIOXIDE AND anesthesia

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

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ClinicalTrials.gov Identifier: NCT03905733
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment
Foreign Bodies Tumor Stenosis of Trachea Bronchus Device: Optiflow

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. 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

  2. the lowest oxygen saturation [ Time Frame: apnea period during the rigidbroscopic procedure/surgery ]
    the lowest value of oxygen saturation measured percutaneously at extremity.

  3. 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


Secondary Outcome Measures :
  1. 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. ]
  2. 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) ]


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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905733


Locations
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Korea, Republic of
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Chang Young Lee, MD    82-10-2720-7399    CYLEECS@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03905733     History of Changes
Other Study ID Numbers: 1-2019-0009
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tracheal Stenosis
Foreign Bodies
Tracheal Diseases
Respiratory Tract Diseases
Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs