Clinical trial NCT03086265: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery
Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otorhinolaryngologic Surgical Procedures
Laser Therapy
Keywords: airway management
high flow nasal oxygen high flow nasal cannula THRIVE
high flow nasal cannula THRIVE
THRIVE
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-03-22
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 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).


Eligibility criteria: Inclusion Criteria:

* Patients presenting for laser laryngeal 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 oxygen saturation (SpO2) \< 95% .
11. Obese patients with BMI \> 35 kg/m2.
12. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
13. Patients with hiatal hernia and full stomach patients.
14. Patient's refusal to participate in the study.
15. Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.

Primary outcomes:
measure: Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Partial Pressure of Oxygen in the Arterial Blood (PaO2)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
measure: Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
measure: pH in Blood
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
measure: Heart Rate
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
measure: Mean Arterial Pressure (MAP)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
measure: Stroke Volume Index (SVI)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
measure: Cardiac Index (CI)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
measure: Systemic Vascular Resistance Index (SVRI)
timeFrame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
measure: Awakening/Extubation Time
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Time to Suspension
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Number of Suspension Adjustments
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Duration of Surgery
timeFrame: Duration of surgery (average approximately 1 hour)
Secondary outcomes:
measure: Count of Participants Requiring Jet Ventilation
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Time to Spontaneous Ventilation
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Apnea Time
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Duration of Anesthesia
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Total Propofol Dose (Anesthetic)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Total Remifentanil Dose (Anesthetic)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Total Phenylephrine Dose (Vasoactive Drug)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Total Ephedrine Dose (Vasoactive Drug)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Total Labetalol Dose (Vasoactive Drug)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Time to Patient Being Alert and Oriented x 4
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Recovery Room Discharge-ready Time
timeFrame: Duration of recovery room stay (average approximately 1 hour)
measure: First Pain Score in Recovery Room
timeFrame: Duration of recovery room stay (average approximately 1 hour)
measure: Pain Score at Discharge From Recovery Room
timeFrame: Duration of recovery room stay (average approximately 1 hour)
measure: Analgesic Consumption
timeFrame: Recovery room to 7th postoperative day
measure: Quality of Recovery (QoR)15 Score
timeFrame: Prior to procedure, and 1-2 hours after procedure
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: