An interventional study of High-flow nasal cannula and simple mask in Head and Neck Neoplasm, sponsored by Asan Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-07.
Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment
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.
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
2,402 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 52 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
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Exclusion Criteria:
pre-oxygenation with High-flow nasal cannula
Device: High-flow nasal cannula
pre-oxygenation with simple mask
Device: simple mask
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.
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.
PaO2 (arterial oxygen partial pressure) at pre-defined time points.
changes of PaO2
Time frame: through study completion, an average of 10 minutes
degree of blood oxygenation oxygenation
result of arterial blood gas analysis
Time frame: through study completion, an average of 10 minutes
various patients' characteristics about airway
upper lip bite test classification (class 1\~3)
Time frame: through study completion, an average of 10 minutes
degree of difficulty for intubation
the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist
Time frame: through study completion, an average of 10 minutes
degree of tissue oxygenation
O2 saturation
Time frame: through study completion, an average of 10 minutes
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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