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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03629353
Other study ID # THRIVE during LMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 17, 2018
Est. completion date February 24, 2020

Study information

Verified date September 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date February 24, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endotracheal 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.
high 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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary lowest oxygen saturation lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery from the time of starting laryngeal microsurgery till the end of the surgery
Secondary lowest oxygen reserve index lowest oxygen reserve index monitored during laryngeal microsurgery from the time of starting laryngeal microsurgery till the end of the surgery
Secondary highest transcutaneous partial pressure of carbon dioxide highest transcutaneous partial pressure of carbon dioxide monitored during laryngeal microsurgery from the time of starting laryngeal microsurgery till the end of the surgery
See also
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Terminated NCT03694379 - Apneic Oxygenation Including Precipitous Intubations During RSI in the ED N/A
Terminated NCT05234424 - Flow Rate Impact on Arterial Carbon Dioxide During THRIVE N/A
Completed NCT03195504 - High-flow Nasal Oxygenation in Obese Patients During Apnea N/A