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High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629911
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine

Study Description
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Brief Summary:

Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.


Condition or disease Intervention/treatment Phase
Gastric Distention Device: THRIVE Not Applicable

Detailed Description:

HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.

In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery
Actual Study Start Date : November 23, 2020
Actual Primary Completion Date : August 24, 2021
Actual Study Completion Date : August 24, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: HFNO arm
Patients will receive HFNO therapy during laryngomicrosurgery.
 Device: THRIVE
Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.
Other Name: Optiflow


Outcome Measures
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Primary Outcome Measures :
  1. change of gastric volume [ Time Frame: before HFNO application (baseline), immediately after HFNO application ]
    Ultrasound exam will measure the antral cross-sectional area of gastric antrum


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiology physical status classification I and II
  • Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

  • gastroesophageal reflux
  • gastric pathology
  • pregnancy
  • major cardiovascular, pulmonary, or cerebrovascular disease
  • severe obesity (body mass index>35 kg/m2)
Contacts and Locations
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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): NCT04629911


Locations
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Korea, Republic of
Ajou University Hospital
Suwon, Gyeongki-do, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
More Information
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Responsible Party: Jong Yeop Kim, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT04629911    
Other Study ID Numbers: MED-DE1-20-424
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022

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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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Dilatation, Pathologic
Pathological Conditions, Anatomical