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

Head and Neck Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896906
• Other study ID #: 2019-0275
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: April 7, 2020

Study information

• Verified date: May 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 7, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Device:
• High-flow nasal cannula
Apply high ?ow heated (34 °C) and humidified nasal oxygen with the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand) using a ?ow 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 mask
Perform standard preoxygenation by oxygen insufflation via a face mask using the standard anesthesia ventilators (semicircular system) with 100% oxygen ?ow of 12 liter/minute. The patients breathe with tidal volume.

Locations

Country	Name	City	State
Korea, Republic of	Jun-Young Jo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2 (arterial oxygen partial pressure) at pre-defined time points.	changes of PaO2	through study completion, an average of 10 minutes
Secondary	degree of blood oxygenation oxygenation	result of arterial blood gas analysis	through study completion, an average of 10 minutes
Secondary	various patients' characteristics about airway	upper lip bite test classification (class 1~3)	through study completion, an average of 10 minutes
Secondary	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
Secondary	degree of tissue oxygenation	O2 saturation	through study completion, an average of 10 minutes