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Completed

NCT Number: NCT03086265

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

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).

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Key information

Conditions

Otorhinolaryngologic Surgical Procedures Laser Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THRIVE

Device

active nasal oxygen delivery system

Endotracheal tube

Device

Plastic tube for supporting ventilation during surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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