Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.

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

Conditions
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Bronchoscopy

Intervention / Treatment
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* Device: THRIVE
* Device: Endotracheal tube or Supraglottic airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for diagnostic bronchoscopy 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. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment. Patients with hiatal hernia and full stomach patients. Patients on immunosuppressive medications. 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 or supraglottic airway<br>tracheal intubation or supraglottic airway device | Device: Endotracheal tube or Supraglottic airway<br>* Plastic devices for mechanical ventilation<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) | 
| 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 Bronchoscope Placement in Trachea | Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement. | Duration of surgery (average approximately 1 hour) | 
| Number of Tracheal Bronchoscope Placements Required |  | Duration of surgery (average approximately 1 hour) | 
| Duration of Procedure | Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure. | Duration of surgery (average approximately 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Patient Being Alert and Oriented x 4 | Recorded from patient's admission to the post-anesthesia care unit (PACU) 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 was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Duration of recovery room stay (average approximately 1 hour) | 
| Discharge-ready Pain Score | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Day of discharge (up to 2 minutes) | 
| Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | Recovery room to 7th postoperative day | 

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