NCT03629353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

November 20, 2020

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

August 9, 2018

Last Update Submit

November 19, 2020

Conditions

Apneic Oxygenation

Keywords

airway managementhigh flow nasal cannulalaryngeal microsurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • lowest oxygen reserve index

    from the time of starting laryngeal microsurgery till the end of the surgery

  • highest transcutaneous partial pressure of carbon dioxide

    from the time of starting laryngeal microsurgery till the end of the surgery

Study Arms (2)

intubation group

EXPERIMENTAL

The enrolled patients will be oxygenated by endotracheal tube during operation.

Procedure: endotracheal intubation

THRIVE group

EXPERIMENTAL

The enrolled patients will be oxygenated by intubationless high flow nasal cannula during operation.

Procedure: high flow nasal cannula

Interventions

endotracheal intubationPROCEDURE

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.

intubation group
high flow nasal cannulaPROCEDURE

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.

THRIVE group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing laryngeal microsurgery
  • ASA class I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34688473DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

August 17, 2018

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

November 20, 2020

Record last verified: 2018-09

Locations

KR(1)