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Completed

NCT Number: NCT03091179

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery

The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube 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 cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).

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Key information

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 short, non-laser laryngologic 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 SpO2 < 95%.
  • Obese patients with BMI above 35 kg/m2.
  • Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
  • Patients with hiatal hernia and full stomach patients. 15. Patient's refusal to participate in the study. 16. Patients who do not understand English or mentally handicapped. 17. Pregnant or breastfeeding patients.

Treatment and study plan

THRIVE

Device

active nasal oxygen delivery system

Endotracheal tube

Device

a plastic tube for mechanical ventilation

Primary outcomes

  1. Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)

    Time frame: intraoperative (up to one hour)

  2. Time to Awakening From Anesthesia (Primary Anesthesia Outcome)

    Time frame: intraoperative (up to 20 min)

    time from end of surgery to responding to commands/extubation

  3. Suspension Time (Primary Surgical Outcome)

    Time frame: intraoperative (up to 5 min)

    Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope

  4. Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)

    Time frame: intraoperative (up to 5 min)

    Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope

  5. Duration of Surgery (Primary Surgical Outcome)

    Time frame: intraoperative (up to one hour)

Secondary outcomes

  1. Alertness

    Time frame: Recovery room admission (up to 30 min following admission to recovery room)

    Time required for the patient to become fully alert and oriented per standard recovery room evaluation

  2. Recovery Room Time

    Time frame: Up to 2 hours after procedure

  3. Numerical Pain Rating Scores

    Time frame: Recovery room admission and discharge (up to 2 hours)

    A score from 0 to 10, higher scores corresponding to higher pain

  4. Opioid Consumption

    Time frame: Recovery room admission and discharge (up to 2 hours)

    Total oral opioid consumption in morphine milligram equivalents

  5. Change in Voice Handicap Index (VHI)

    Time frame: Preoperative assessment and one month after surgery

    numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome

  6. Quality of Recovery

    Time frame: One week after surgery

    15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.

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 Short Laryngologic Surgical Procedures.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Mar 4, 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.