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Preoxygenation With High-flow Nasal Cannula

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ClinicalTrials.gov Identifier: NCT03896906
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Seong-Soo Choi, MD, PhD, Asan Medical Center

Brief Summary:

Objectives: To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes Methods: This randomized, single-blinded, prospective study was conducted at Asan Medical Center in Seoul, Republic of Korea.

Populations: Patients undergoing head and neck surgery Expected outcomes: The course of PaO2 levels is superior to those of the face mask during the whole preoxygenation procedure and after the intubation.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasm Device: High-flow nasal cannula Device: simple mask Not Applicable

Detailed Description:

Rationale & background information:

Pre-oxygenation before general anesthesia is usually achieved using oxygen delivered via a facemask before induction of anesthesia; this potentially extends the time available for securing the airway before hypoxemia to 6 min. The lungs are commonly ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged. However, facemask ventilation has traditionally been avoided in the circumstance which has the risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. In addition, if difficult ventilation is anticipated, facemask ventilation may not be possible at all, and 6 minutes with hypoxemia may be insufficient for intubation.

An ideal preoxygenation to extend apnea tolerance during anesthesia induction is essential to avoid live threatening airway incidents. The high-flow nasal cannula, the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand), has the ability to deliver warmed and humidified oxygen through specially designed nasal cannula and enable oxygen to be comfortably delivered at rates of > 70 liter/min. Several study showed that nasal delivery of humidified oxygen to paralyzed and anesthetized patients at these rates maintains oxygenation and achieves acceptable carbon dioxide concentration. The investigators hypothesized that an extended apneic period without facemask ventilation could be particularly beneficial to patients undergoing general anaesthesia.

Study goals and objectives:

To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoxygenation With High-flow Nasal Cannula Versus Simple Mask Before Intubation During Induction of General Anesthesia
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Group N
pre-oxygenation with High-flow nasal cannula
Device: High-flow nasal cannula
Apply high flow heated (34 °C) and humidified nasal oxygen with the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand) using a flow of 30 liter/minute and an inspiratory oxygen fraction (FiO2) of 1.0. Increase the oxygen flow to 60 liter/minute over the course of the first minute. Ask the patients not to speak during anesthesia induction and keep the mouth closed.

Active Comparator: Group M
pre-oxygenation with simple mask
Device: simple mask
Perform standard preoxygenation by oxygen insufflation via a face mask using the standard anesthesia ventilators (semicircular system) with 100% oxygen flow of 12 liter/minute. The patients breathe with tidal volume.




Primary Outcome Measures :
  1. PaO2 (arterial oxygen partial pressure) at pre-defined time points. [ Time Frame: through study completion, an average of 10 minutes ]
    changes of PaO2


Secondary Outcome Measures :
  1. degree of blood oxygenation oxygenation [ Time Frame: through study completion, an average of 10 minutes ]
    result of arterial blood gas analysis

  2. various patients' characteristics about airway [ Time Frame: through study completion, an average of 10 minutes ]
    upper lip bite test classification (class 1~3)

  3. degree of difficulty for intubation [ Time Frame: through study completion, an average of 10 minutes ]
    the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist

  4. degree of tissue oxygenation [ Time Frame: through study completion, an average of 10 minutes ]
    O2 saturation



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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:

  1. Patients with head and neck cancer undergoing resection surgery planned arterial cannulation and invasive arterial blood pressure monitoring and arterial blood gas analysis
  2. Patients over 19-year old
  3. Patients who voluntarily participated in the study
  4. Patents in American Society of Anesthesia physical status 1-3

Exclusion Criteria:

  1. Patients who don't approve to participation
  2. Unable to give informed consent because of a language barrier
  3. Patients with severe respiratory disease
  4. Patients with severe cardiovascular or cerebrovascular disease
  5. Patients with severe psychiatric disorders
  6. Anyone who is not appropriate according to researcher's decision

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): NCT03896906


Contacts
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Contact: Jun Jo, Dr. +82-10-9013-0910 junyoung.jo@gmail.com

Locations
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Korea, Republic of
Jun Young Jo Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jun Young Jo       junyoung.jo@gmail.com   
Sponsors and Collaborators
Asan Medical Center

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Responsible Party: Seong-Soo Choi, MD, PhD, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03896906     History of Changes
Other Study ID Numbers: 2019-0275
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Seong-Soo Choi, MD, PhD, Asan Medical Center:
preoxygenation
high-flow nasal cannula
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms