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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
active nasal oxygen delivery system
Plastic tube for supporting ventilation during surgery
Stanford Hospital and Clinics
Stanford, California, United States
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Time frame: Duration of surgery (average approximately 1 hour)
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Time frame: 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)
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
pH in Blood
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.
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Heart Rate
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Mean Arterial Pressure (MAP)
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Stroke Volume Index (SVI)
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).
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
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Cardiac Index (CI)
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 frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Systemic Vascular Resistance Index (SVRI)
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).
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (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.
Time frame: Duration of surgery (average approximately 1 hour)
Time to Suspension
Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Time frame: Duration of surgery (average approximately 1 hour)
Number of Suspension Adjustments
Number of adjustments of the suspension laryngoscope.
Time frame: Duration of surgery (average approximately 1 hour)
Duration of Surgery
Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.
Time frame: Duration of surgery (average approximately 1 hour)
Count of Participants Requiring Jet Ventilation
Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Time frame: Duration of surgery (average approximately 1 hour)
Time to Spontaneous Ventilation
Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
Time frame: Duration of surgery (average approximately 1 hour)
Apnea Time
Recorded from induction of anesthesia to the return of spontaneous ventilation.
Time frame: Duration of surgery (average approximately 1 hour)
Duration of Anesthesia
Recorded from induction of anesthesia to patient's awakening/extubation
Time frame: Duration of surgery (average approximately 1 hour)
Total Propofol Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
Total Remifentanil Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
Total Phenylephrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Total Ephedrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Total Labetalol Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Time to Patient Being Alert and Oriented x 4
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.
Time frame: Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time
From admission to recovery room, to discharge from recovery room
Time frame: Duration of recovery room stay (average approximately 1 hour)
First Pain Score in Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time frame: Duration of recovery room stay (average approximately 1 hour)
Pain Score at Discharge From Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time frame: Duration of recovery room stay (average approximately 1 hour)
Analgesic Consumption
Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Time frame: Recovery room to 7th postoperative day
Quality of Recovery (QoR)15 Score
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 frame: Prior to procedure, and 1-2 hours after procedure