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

NCT03086265 | Completed Results FDA Device

• 1 other identifier: 36060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Otorhinolaryngologic Surgical Procedures; Laser Therapy

Keywords

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

Outcome Measures

Primary Outcomes (13)

• Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

  Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.

  Duration of surgery (average approximately 1 hour)

• 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)

• 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.

  Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)

• Heart Rate

  Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

• Mean Arterial Pressure (MAP)

  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).

  Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)

• 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.

  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).

  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.

  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.

  Duration of surgery (average approximately 1 hour)

• Number of Suspension Adjustments

  Number of adjustments of the suspension laryngoscope.

  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.

  Duration of surgery (average approximately 1 hour)

Secondary Outcomes (15)

• Count of Participants Requiring Jet Ventilation

  Duration of surgery (average approximately 1 hour)

• Time to Spontaneous Ventilation

  Duration of surgery (average approximately 1 hour)

• Apnea Time

  Duration of surgery (average approximately 1 hour)

• Duration of Anesthesia

  Duration of surgery (average approximately 1 hour)

• Total Propofol Dose (Anesthetic)

  Duration of surgery (average approximately 1 hour)

Study Arms (2)

THRIVE

EXPERIMENTAL

high flow nasal oxygen

Device: THRIVE

Endotracheal tube

ACTIVE COMPARATOR

tracheal intubation

Device: Endotracheal tube

Interventions

THRIVE DEVICE

active nasal oxygen delivery system

THRIVE

Endotracheal tube DEVICE

Plastic tube for supporting ventilation during surgery

Endotracheal tube

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for laser laryngeal surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Vladimir Nekhendzy, M.D., FASA
• Organization: Stanford University

nek@stanford.edu

650-498-4055

Study Officials

• Vladimir Nekhendzy, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology and Otolaryngology

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 22, 2017
• Study Start: March 24, 2017
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)