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Preoxygenation With a High-flow Nasal Cannula or a Simple Mask Before General Anesthesia in Head and Neck Surgery

Primary Purpose

Head and Neck Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High-flow nasal cannula
simple mask
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasm focused on measuring preoxygenation, high-flow nasal cannula

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jun-Young Jo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group N

Group M

Arm Description

pre-oxygenation with High-flow nasal cannula

pre-oxygenation with simple mask

Outcomes

Primary Outcome Measures

PaO2 (arterial oxygen partial pressure) at pre-defined time points.
changes of PaO2

Secondary Outcome Measures

degree of blood oxygenation oxygenation
result of arterial blood gas analysis
various patients' characteristics about airway
upper lip bite test classification (class 1~3)
degree of difficulty for intubation
the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist
degree of tissue oxygenation
O2 saturation

Full Information

First Posted
March 6, 2019
Last Updated
May 6, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03896906
Brief Title
Preoxygenation With a High-flow Nasal Cannula or a Simple Mask Before General Anesthesia in Head and Neck Surgery
Official Title
Comparison of Preoxygenation With a High-flow Nasal Cannula and a Simple Mask Before Intubation During Induction of General Anesthesia in Patients Undergoing Head and Neck Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
April 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm
Keywords
preoxygenation, high-flow nasal cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group N
Arm Type
Experimental
Arm Description
pre-oxygenation with High-flow nasal cannula
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
pre-oxygenation with simple mask
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
simple mask
Intervention Description
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 Measure Information:
Title
PaO2 (arterial oxygen partial pressure) at pre-defined time points.
Description
changes of PaO2
Time Frame
through study completion, an average of 10 minutes
Secondary Outcome Measure Information:
Title
degree of blood oxygenation oxygenation
Description
result of arterial blood gas analysis
Time Frame
through study completion, an average of 10 minutes
Title
various patients' characteristics about airway
Description
upper lip bite test classification (class 1~3)
Time Frame
through study completion, an average of 10 minutes
Title
degree of difficulty for intubation
Description
the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist
Time Frame
through study completion, an average of 10 minutes
Title
degree of tissue oxygenation
Description
O2 saturation
Time Frame
through study completion, an average of 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with head and neck cancer undergoing resection surgery planned arterial cannulation and invasive arterial blood pressure monitoring and arterial blood gas analysis Patients over 19-year old Patients who voluntarily participated in the study Patents in American Society of Anesthesia physical status 1-3 Exclusion Criteria: Patients who don't approve to participation Unable to give informed consent because of a language barrier Patients with severe respiratory disease Patients with severe cardiovascular or cerebrovascular disease Patients with severe psychiatric disorders Anyone who is not appropriate according to researcher's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Soo Choi, Dr.
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jun-Young Jo
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32195955
Citation
Jo JY, Kim WJ, Ku S, Choi SS. Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Mar;99(12):e19525. doi: 10.1097/MD.0000000000019525.
Results Reference
derived

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Preoxygenation With a High-flow Nasal Cannula or a Simple Mask Before General Anesthesia in Head and Neck Surgery

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