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The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange During Laryngeal Microsurgery

The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03629353
Enrollment
126
Registered
2018-08-14
Start date
2018-08-17
Completion date
2020-02-24
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apneic Oxygenation

Keywords

airway management, high flow nasal cannula, laryngeal microsurgery

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.

Interventions

PROCEDUREendotracheal intubation

After preoxygenation with FiO2 1.0 and flow rate of 8 L/min for 3 minutes, the enrolled patients will be intubated with endotracheal tube and maintained oxygenation during surgery.

PROCEDUREhigh flow nasal cannula

After preoxygenation with 100% oxygen through high flow nasal cannula for 3 minutes, the enrolled patients will be maintained intubationless oxygenation with flow rate of 70 L/min during surgery.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
lowest oxygen saturationfrom the time of starting laryngeal microsurgery till the end of the surgerylowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery

Secondary

MeasureTime frameDescription
lowest oxygen reserve indexfrom the time of starting laryngeal microsurgery till the end of the surgerylowest oxygen reserve index monitored during laryngeal microsurgery
highest transcutaneous partial pressure of carbon dioxidefrom the time of starting laryngeal microsurgery till the end of the surgeryhighest transcutaneous partial pressure of carbon dioxide monitored during laryngeal microsurgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026