Clinical trial NCT03896906: Preoxygenation With a High-flow Nasal Cannula or a Simple Mask Before General Anesthesia in Head and Neck Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasm
Keywords: preoxygenation
high-flow nasal cannula
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: PaO2 (arterial oxygen partial pressure) at pre-defined time points.
timeFrame: through study completion, an average of 10 minutes
Secondary outcomes:
measure: degree of blood oxygenation oxygenation
timeFrame: through study completion, an average of 10 minutes
measure: various patients' characteristics about airway
timeFrame: through study completion, an average of 10 minutes
measure: degree of difficulty for intubation
timeFrame: through study completion, an average of 10 minutes
measure: degree of tissue oxygenation
timeFrame: through study completion, an average of 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jun-Young Jo
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Asan Medical Center
name: Seong-Soo Choi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.