Clinical trial NCT03629353: The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange During Laryngeal Microsurgery
Official title: The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apneic Oxygenation
Keywords: airway management
high flow nasal cannula
laryngeal microsurgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.

However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.

Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.

Detailed description: Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.

On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.

The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laryngeal microsurgery
* ASA class I-III

Exclusion Criteria:

* patients scheduled for laryngeal microsurgery using CO2 laser
* patients with increased intracranial pressure
* patients with skull base defect
* patients with chronic obstructive pulmonary disease
* patients with pulmonary hypertension
* patients requiring rapid sequence induction

Primary outcomes:
measure: lowest oxygen saturation
timeFrame: from the time of starting laryngeal microsurgery till the end of the surgery
Secondary outcomes:
measure: lowest oxygen reserve index
timeFrame: from the time of starting laryngeal microsurgery till the end of the surgery
measure: highest transcutaneous partial pressure of carbon dioxide
timeFrame: from the time of starting laryngeal microsurgery till the end of the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min SH, Yoon H, Huh G, Kwon SK, Seo JH, Cho YJ. Efficacy of high-flow nasal oxygenation compared with tracheal intubation for oxygenation during laryngeal microsurgery: a randomised non-inferiority study. Br J Anaesth. 2022 Jan;128(1):207-213. doi: 10.1016/j.bja.2021.09.016. Epub 2021 Oct 20.