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

• ClinicalTrials.gov Identifier: NCT03086265
• Recruitment Status: Completed
• First Posted: March 22, 2017
• Results First Posted: March 17, 2020
• Last Update Posted: March 17, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Vladimir Nekhendzy, Stanford University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Otorhinolaryngologic Surgical Procedures; Laser Therapy	Device: THRIVE; Device: Endotracheal tube	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery
• Actual Study Start Date: March 24, 2017
• Actual Primary Completion Date: February 26, 2019
• Actual Study Completion Date: February 26, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: THRIVE; high flow nasal oxygen	Device: THRIVE; active nasal oxygen delivery system
Active Comparator: Endotracheal tube; tracheal intubation	Device: Endotracheal tube; Plastic tube for supporting ventilation during surgery

Outcome Measures

Primary Outcome Measures :

1. Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
   Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
2. 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) ]
3. 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) ]
4. pH in Blood [ Time Frame: 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.
5. Heart Rate [ Time Frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) ]
6. Mean Arterial Pressure (MAP) [ Time Frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) ]
7. Stroke Volume Index (SVI) [ Time Frame: 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).
8. Cardiac Index (CI) [ Time Frame: 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.
9. Systemic Vascular Resistance Index (SVRI) [ Time Frame: 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).
10. Awakening/Extubation Time [ Time Frame: 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.
11. Time to Suspension [ Time Frame: 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.
12. Number of Suspension Adjustments [ Time Frame: Duration of surgery (average approximately 1 hour) ]
    Number of adjustments of the suspension laryngoscope.
13. Duration of Surgery [ Time Frame: 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.

Secondary Outcome Measures :

1. Count of Participants Requiring Jet Ventilation [ Time Frame: Duration of surgery (average approximately 1 hour) ]
   Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
2. Time to Spontaneous Ventilation [ Time Frame: Duration of surgery (average approximately 1 hour) ]
   Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
3. Apnea Time [ Time Frame: Duration of surgery (average approximately 1 hour) ]
   Recorded from induction of anesthesia to the return of spontaneous ventilation.
4. Duration of Anesthesia [ Time Frame: Duration of surgery (average approximately 1 hour) ]
   Recorded from induction of anesthesia to patient's awakening/extubation
5. Total Propofol Dose (Anesthetic) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
6. Total Remifentanil Dose (Anesthetic) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
7. Total Phenylephrine Dose (Vasoactive Drug) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
8. Total Ephedrine Dose (Vasoactive Drug) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
9. Total Labetalol Dose (Vasoactive Drug) [ Time Frame: Duration of surgery (average approximately 1 hour) ]
10. Time to Patient Being Alert and Oriented x 4 [ Time Frame: 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.
11. Recovery Room Discharge-ready Time [ Time Frame: Duration of recovery room stay (average approximately 1 hour) ]
    From admission to recovery room, to discharge from recovery room
12. First Pain Score in Recovery Room [ Time Frame: Duration of recovery room stay (average approximately 1 hour) ]
    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
13. Pain Score at Discharge From Recovery Room [ Time Frame: Duration of recovery room stay (average approximately 1 hour) ]
    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
14. Analgesic Consumption [ Time Frame: Recovery room to 7th postoperative day ]
    Analgesic consumption was measured in oral morphine milligram equivalents (MME)
15. Quality of Recovery (QoR)15 Score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Vladimir Nekhendzy, MD; Stanford University

  Study Documents (Full-Text)

Documents provided by Vladimir Nekhendzy, Stanford University:

Study Protocol  [PDF] August 12, 2016

Statistical Analysis Plan  [PDF] February 24, 2020

More Information

• Responsible Party: Vladimir Nekhendzy, Clinical Professor of Anesthesiology and Otolaryngology, Stanford University
• ClinicalTrials.gov Identifier: NCT03086265
• Other Study ID Numbers: 36060
• First Posted: March 22, 2017
• Results First Posted: March 17, 2020
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Vladimir Nekhendzy, Stanford University:

airway management; high flow nasal oxygen high flow nasal cannula THRIVE; high flow nasal cannula THRIVE; THRIVE