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

Study Overview
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Brief Summary
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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).

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

Conditions
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Otorhinolaryngologic Surgical Procedures, Laser Therapy

Intervention / Treatment
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* Device: THRIVE
* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for laser laryngeal surgery Exclusion Criteria: Patients with significantly decreased myocardial function (ejection fraction < 50%) Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs) . Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes). Patients with skull base defects. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range. 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% . Obese patients with BMI > 35 kg/m2. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment. Patients with hiatal hernia and full stomach patients. Patient's refusal to participate in the study. Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THRIVE<br>high flow nasal oxygen | Device: THRIVE<br>* active nasal oxygen delivery system<br>|
| Active Comparator: Endotracheal tube<br>tracheal intubation | Device: Endotracheal tube<br>* Plastic tube for supporting ventilation during surgery<br>|

What is the study measuring?
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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) | 
| 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) | 
| 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) | 
| 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 |
| --- | --- | --- |
| 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) | 
| Recovery Room Discharge-ready Time | From admission to recovery room, to discharge from recovery room | Duration of recovery room stay (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) | 
| Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | Recovery room to 7th postoperative day | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management, high flow nasal oxygen high flow nasal cannula THRIVE, high flow nasal cannula THRIVE, THRIVE