Clinical trial NCT03091179: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery
Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngologic Surgical Procedures
Keywords: airway management
high flow nasal oxygen
high flow nasal cannula
THRIVE
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Patients presenting for short, non-laser laryngologic 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 SpO2 \< 95%.
11. 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.

Primary outcomes:
measure: Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
timeFrame: intraoperative (up to one hour)
measure: Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
timeFrame: intraoperative (up to 20 min)
measure: Suspension Time (Primary Surgical Outcome)
timeFrame: intraoperative (up to 5 min)
measure: Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
timeFrame: intraoperative (up to 5 min)
measure: Duration of Surgery (Primary Surgical Outcome)
timeFrame: intraoperative (up to one hour)
Secondary outcomes:
measure: Alertness
timeFrame: Recovery room admission (up to 30 min following admission to recovery room)
measure: Recovery Room Time
timeFrame: Up to 2 hours after procedure
measure: Numerical Pain Rating Scores
timeFrame: Recovery room admission and discharge (up to 2 hours)
measure: Opioid Consumption
timeFrame: Recovery room admission and discharge (up to 2 hours)
measure: Change in Voice Handicap Index (VHI)
timeFrame: Preoperative assessment and one month after surgery
measure: Quality of Recovery
timeFrame: One week after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Vladimir Nekhendzy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.