Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery

Not Applicable

Completed

Conditions: Otorhinolaryngologic Surgical Procedures
Laser Therapy

Interventions: Device: THRIVE
Device: Endotracheal tube

Registration Number: NCT03086265

Lead Sponsor: Stanford University

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients presenting for laser laryngeal 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 oxygen saturation (SpO2) < 95% .
Obese patients with BMI > 35 kg/m2.
Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THRIVE	THRIVE	high flow nasal oxygen
Endotracheal tube	Endotracheal tube	tracheal intubation

Primary Outcome Measures

Name	Time	Method
pH in Blood	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)	The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.
Stroke Volume Index (SVI)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)	Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m\^2).
Cardiac Index (CI)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)	Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index.
Time to Suspension	Duration of surgery (average approximately 1 hour)	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Partial Pressure of Oxygen in the Arterial Blood (PaO2)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Awakening/Extubation Time	Duration of surgery (average approximately 1 hour)	Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Heart Rate	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Duration of Surgery	Duration of surgery (average approximately 1 hour)	Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)	Duration of surgery (average approximately 1 hour)	Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Mean Arterial Pressure (MAP)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Systemic Vascular Resistance Index (SVRI)	Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)	SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne\seconds per centimetre\^5 (dyne\sec/cm\^5).
Number of Suspension Adjustments	Duration of surgery (average approximately 1 hour)	Number of adjustments of the suspension laryngoscope.

Secondary Outcome Measures

Name	Time	Method
Total Remifentanil Dose (Anesthetic)	Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time	Duration of recovery room stay (average approximately 1 hour)	From admission to recovery room, to discharge from recovery room
Pain Score at Discharge From Recovery Room	Duration of recovery room stay (average approximately 1 hour)	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Analgesic Consumption	Recovery room to 7th postoperative day	Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Count of Participants Requiring Jet Ventilation	Duration of surgery (average approximately 1 hour)	Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Apnea Time	Duration of surgery (average approximately 1 hour)	Recorded from induction of anesthesia to the return of spontaneous ventilation.
Total Propofol Dose (Anesthetic)	Duration of surgery (average approximately 1 hour)
Total Ephedrine Dose (Vasoactive Drug)	Duration of surgery (average approximately 1 hour)
Time to Patient Being Alert and Oriented x 4	Duration of surgery (average approximately 1 hour)	Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.
Duration of Anesthesia	Duration of surgery (average approximately 1 hour)	Recorded from induction of anesthesia to patient's awakening/extubation
Total Phenylephrine Dose (Vasoactive Drug)	Duration of surgery (average approximately 1 hour)
Total Labetalol Dose (Vasoactive Drug)	Duration of surgery (average approximately 1 hour)
First Pain Score in Recovery Room	Duration of recovery room stay (average approximately 1 hour)	Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Quality of Recovery (QoR)15 Score	Prior to procedure, and 1-2 hours after procedure	The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.
Time to Spontaneous Ventilation	Duration of surgery (average approximately 1 hour)	Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.