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

Not Applicable

Completed

• Conditions: Head and Neck Neoplasm
• Interventions: Device: High-flow nasal cannula; Device: simple mask

• Registration Number: NCT03896906
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Study Start: 2019-05-08
• Primary Completion: 2020-04-07
• Study Completion: 2020-04-07
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group N	High-flow nasal cannula	pre-oxygenation with High-flow nasal cannula
Group M	simple mask	pre-oxygenation with simple mask

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jun-Young Jo; 🇰🇷 Seoul, Korea, Republic of