Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery

The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical Procedures.

The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

Study Overview

• Status: Completed
• Conditions: Laryngologic Surgical Procedures
• Intervention / Treatment: Device: THRIVE; Device: Endotracheal tube

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients presenting for short, non-laser laryngologic surgery

Exclusion Criteria:

1. Patients with significantly decreased myocardial function (ejection fraction < 50%)
2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2.
6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
8. Patients with skull base defects.
9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
10. Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 < 95%.
11. Obese patients with BMI above 35 kg/m2.

13. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

14. Patients with hiatal hernia and full stomach patients. 15. Patient's refusal to participate in the study. 16. Patients who do not understand English or mentally handicapped. 17. Pregnant or breastfeeding patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THRIVE; high flow nasal oxygen	Device: THRIVE; active nasal oxygen delivery system
Active Comparator: Endotracheal tube; tracheal intubation	Device: Endotracheal tube; a plastic tube for mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)		intraoperative (up to one hour)
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)	time from end of surgery to responding to commands/extubation	intraoperative (up to 20 min)
Suspension Time (Primary Surgical Outcome)	Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope	intraoperative (up to 5 min)
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)	Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope	intraoperative (up to 5 min)
Duration of Surgery (Primary Surgical Outcome)		intraoperative (up to one hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alertness	Time required for the patient to become fully alert and oriented per standard recovery room evaluation	Recovery room admission (up to 30 min following admission to recovery room)
Recovery Room Time		Up to 2 hours after procedure
Numerical Pain Rating Scores	A score from 0 to 10, higher scores corresponding to higher pain	Recovery room admission and discharge (up to 2 hours)
Opioid Consumption	Total oral opioid consumption in morphine milligram equivalents	Recovery room admission and discharge (up to 2 hours)
Change in Voice Handicap Index (VHI)	numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome	Preoperative assessment and one month after surgery
Quality of Recovery	15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.	One week after surgery

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Vladimir Nekhendzy, MD, Stanford University

Publications and helpful links

General Publications

• Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: airway management; high flow nasal cannula; high flow nasal oxygen; THRIVE
• Other Study ID Numbers: 39202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No