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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasm
• Intervention / Treatment: Device: High-flow nasal cannula; Device: simple mask

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Jun-Young Jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2 (arterial oxygen partial pressure) at pre-defined time points.	changes of PaO2	through study completion, an average of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of blood oxygenation oxygenation	result of arterial blood gas analysis	through study completion, an average of 10 minutes
various patients' characteristics about airway	upper lip bite test classification (class 1~3)	through study completion, an average of 10 minutes
degree of difficulty for intubation	the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist	through study completion, an average of 10 minutes
degree of tissue oxygenation	O2 saturation	through study completion, an average of 10 minutes

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Seong-Soo Choi, Dr., Department of Anesthesiology and Pain Medicine, Asan Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): April 7, 2020

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: preoxygenation; high-flow nasal cannula
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2019-0275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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