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

Study Overview
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Brief Summary
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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).

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

Conditions
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Laryngologic Surgical Procedures

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 short, non-laser laryngologic 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 SpO2 < 95%. 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.

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>* a plastic tube for mechanical ventilation<br>|

What is the study measuring?
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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 | 

 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