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NCT Number: NCT03629353

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

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.

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Key information

Conditions

Apneic Oxygenation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal Intubation

Procedure

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

Procedure

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.

Primary outcomes

  1. 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

  1. lowest oxygen reserve index

    Time frame: from the time of starting laryngeal microsurgery till the end of the surgery

    lowest oxygen reserve index monitored during laryngeal microsurgery

  2. highest transcutaneous partial pressure of carbon dioxide

    Time frame: from the time of starting laryngeal microsurgery till the end of the surgery

    highest transcutaneous partial pressure of carbon dioxide monitored during laryngeal microsurgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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