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

NCT03896906 | Completed

• 1 other identifier: 2019-0275
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasm

Keywords

preoxygenation; high-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

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

  changes of PaO2

  through study completion, an average of 10 minutes

Secondary Outcomes (4)

• degree of blood oxygenation oxygenation

  through study completion, an average of 10 minutes

• various patients' characteristics about airway

  through study completion, an average of 10 minutes

• degree of difficulty for intubation

  through study completion, an average of 10 minutes

• degree of tissue oxygenation

  through study completion, an average of 10 minutes

Study Arms (2)

Group N

EXPERIMENTAL

pre-oxygenation with High-flow nasal cannula

Device: High-flow nasal cannula

Group M

ACTIVE COMPARATOR

pre-oxygenation with simple mask

Device: simple mask

Interventions

High-flow nasal cannula DEVICE

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.

Group N

simple mask DEVICE

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.

Group M

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Jun-Young Jo

Seoul, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32195955 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Seong-Soo Choi, Dr.

  Department of Anesthesiology and Pain Medicine, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 1, 2019
• Study Start: May 8, 2019
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)