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Head and Neck NeoplasmNCT03896906

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

A study testing High-flow nasal cannula and simple mask in people with Head and Neck Neoplasm, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Head and Neck Neoplasm
What is being tested?
High-flow nasal cannula and simple mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSouth Korea
Study dates
8 May 2019to 7 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jun-Young Jo

    Seoul, 05505

Other trials in South Korea

About this study

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

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.

Read the 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

Being tested
High-flow nasal cannula, simple mask
Keywords
preoxygenation, high-flow nasal cannula
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-flow nasal cannulaDevice

    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.

  • simple maskDevice

    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.

Study groups in NCT03896906
Study groupRoleWhat they receive
Group NExperimentalpre-oxygenation with High-flow nasal cannula
Receives: Device: High-flow nasal cannula
Group MActive comparatorpre-oxygenation with simple mask
Receives: Device: simple mask

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    changes of PaO2

    Measured: through study completion, an average of 10 minutes

Secondary outcomes (4)

  1. degree of blood oxygenation oxygenation

    result of arterial blood gas analysis

    Measured: through study completion, an average of 10 minutes

  2. various patients' characteristics about airway

    upper lip bite test classification (class 1~3)

    Measured: through study completion, an average of 10 minutes

  3. degree of difficulty for intubation

    the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist

    Measured: through study completion, an average of 10 minutes

  4. degree of tissue oxygenation

    O2 saturation

    Measured: through study completion, an average of 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start8 May 2019
  3. Primary completion7 Apr 2020
  4. Study completion7 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896906
Sponsor's protocol ID
2019-0275
Status last verified
May 2020
First submitted
6 Mar 2019
Last updated
7 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32195955

Questions about this trial

What is this clinical trial studying?

A study testing High-flow nasal cannula and simple mask in people with Head and Neck Neoplasm, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PaO2 (arterial oxygen partial pressure) at pre-defined time points. (time frame: through study completion, an average of 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03896906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.

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