Preoxygenation With High-flow Nasal Cannula
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|ClinicalTrials.gov Identifier: NCT03896906|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasm||Device: High-flow nasal cannula Device: simple mask||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoxygenation With High-flow Nasal Cannula Versus Simple Mask Before Intubation During Induction of General Anesthesia|
|Actual Study Start Date :||May 8, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Group N
pre-oxygenation with High-flow nasal cannula
Device: High-flow nasal cannula
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.
Active Comparator: Group M
pre-oxygenation with simple mask
Device: simple mask
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. [ Time Frame: through study completion, an average of 10 minutes ]changes of PaO2
- degree of blood oxygenation oxygenation [ Time Frame: through study completion, an average of 10 minutes ]result of arterial blood gas analysis
- various patients' characteristics about airway [ Time Frame: through study completion, an average of 10 minutes ]upper lip bite test classification (class 1~3)
- degree of difficulty for intubation [ Time Frame: through study completion, an average of 10 minutes ]the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist
- degree of tissue oxygenation [ Time Frame: through study completion, an average of 10 minutes ]O2 saturation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896906
|Contact: Jun Jo, Dr.||+firstname.lastname@example.org|
|Korea, Republic of|
|Jun Young Jo||Recruiting|
|Seoul, Korea, Republic of, 05505|
|Contact: Jun Young Jo email@example.com|