Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery

The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery

The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation 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 cannula: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

Study Overview

• Status: Completed
• Conditions: Laser Therapy; Otorhinolaryngologic 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 laser laryngeal 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 oxygen saturation (SpO2) < 95% .
11. Obese patients with BMI > 35 kg/m2.
12. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
13. Patients with hiatal hernia and full stomach patients.
14. Patient's refusal to participate in the study.
15. Patients who do not understand English or mentally handicapped. 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; Plastic tube for supporting ventilation during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)	Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.	Duration of surgery (average approximately 1 hour)
Awakening/Extubation Time	Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.	Duration of surgery (average approximately 1 hour)
Partial Pressure of Oxygen in the Arterial Blood (PaO2)		Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)		Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
pH in Blood	The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Heart Rate		Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Mean Arterial Pressure (MAP)		Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Stroke Volume Index (SVI)	Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Cardiac Index (CI)	Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Systemic Vascular Resistance Index (SVRI)	SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Time to Suspension	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.	Duration of surgery (average approximately 1 hour)
Number of Suspension Adjustments	Number of adjustments of the suspension laryngoscope.	Duration of surgery (average approximately 1 hour)
Duration of Surgery	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.	Duration of surgery (average approximately 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery Room Discharge-ready Time	From admission to recovery room, to discharge from recovery room	Duration of recovery room stay (average approximately 1 hour)
Analgesic Consumption	Analgesic consumption was measured in oral morphine milligram equivalents (MME)	Recovery room to 7th postoperative day
Count of Participants Requiring Jet Ventilation	Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.	Duration of surgery (average approximately 1 hour)
Time to Spontaneous Ventilation	Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.	Duration of surgery (average approximately 1 hour)
Apnea Time	Recorded from induction of anesthesia to the return of spontaneous ventilation.	Duration of surgery (average approximately 1 hour)
Duration of Anesthesia	Recorded from induction of anesthesia to patient's awakening/extubation	Duration of surgery (average approximately 1 hour)
Total Propofol Dose (Anesthetic)		Duration of surgery (average approximately 1 hour)
Total Remifentanil Dose (Anesthetic)		Duration of surgery (average approximately 1 hour)
Total Phenylephrine Dose (Vasoactive Drug)		Duration of surgery (average approximately 1 hour)
Total Ephedrine Dose (Vasoactive Drug)		Duration of surgery (average approximately 1 hour)
Total Labetalol Dose (Vasoactive Drug)		Duration of surgery (average approximately 1 hour)
Time to Patient Being Alert and Oriented x 4	Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.	Duration of surgery (average approximately 1 hour)
First Pain Score in Recovery Room	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).	Duration of recovery room stay (average approximately 1 hour)
Pain Score at Discharge From Recovery Room	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).	Duration of recovery room stay (average approximately 1 hour)
Quality of Recovery (QoR)15 Score	The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.	Prior to procedure, and 1-2 hours after procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: airway management; THRIVE; high flow nasal oxygen high flow nasal cannula THRIVE; high flow nasal cannula THRIVE
• Other Study ID Numbers: 36060

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