The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical Procedures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 m
- •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/m
- •13. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
- •14. 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.
Arms & Interventions
THRIVE
high flow nasal oxygen
Intervention: THRIVE (Device)
Endotracheal tube
tracheal intubation
Intervention: Endotracheal tube (Device)
Outcomes
Primary Outcomes
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
Time Frame: intraoperative (up to one hour)
Duration of Surgery (Primary Surgical Outcome)
Time Frame: intraoperative (up to one hour)
Suspension Time (Primary Surgical Outcome)
Time Frame: intraoperative (up to 5 min)
Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
Time Frame: intraoperative (up to 5 min)
Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
Time Frame: intraoperative (up to 20 min)
time from end of surgery to responding to commands/extubation
Secondary Outcomes
- Opioid Consumption(Recovery room admission and discharge (up to 2 hours))
- Change in Voice Handicap Index (VHI)(Preoperative assessment and one month after surgery)
- Alertness(Recovery room admission (up to 30 min following admission to recovery room))
- Quality of Recovery(One week after surgery)
- Numerical Pain Rating Scores(Recovery room admission and discharge (up to 2 hours))
- Recovery Room Time(Up to 2 hours after procedure)
Investigators
Vladimir Nekhendzy
Clinical Professor of Anesthesiology and Otolaryngology
Stanford University