The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- lowest oxygen saturation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
lowest oxygen saturation
Time Frame: from the time of starting laryngeal microsurgery till the end of the surgery
lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery
Secondary Outcomes
- highest transcutaneous partial pressure of carbon dioxide(from the time of starting laryngeal microsurgery till the end of the surgery)
- lowest oxygen reserve index(from the time of starting laryngeal microsurgery till the end of the surgery)
Investigators
Youn Joung Cho, MD
Clinical assistant professor
Seoul National University Hospital