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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091179
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : July 17, 2019
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Vladimir Nekhendzy, Stanford University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Laryngologic Surgical Procedures Device: THRIVE Device: Endotracheal tube Not Applicable

Study Design
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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 Short Laryngologic Surgical Procedures.
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
a plastic tube for mechanical ventilation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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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 short, non-laser laryngologic 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 SpO2 < 95%.
  11. Obese patients with BMI above 35 kg/m2.

13. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

14. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091179


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Vladimir Nekhendzy, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Vladimir Nekhendzy, Stanford University:
Statistical Analysis Plan  [PDF] June 20, 2019
Study Protocol  [PDF] February 15, 2017

More Information
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Publications of Results:

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Responsible Party: Vladimir Nekhendzy, Clinical Professor of Anesthesiology and Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT03091179    
Other Study ID Numbers: 39202
First Posted: March 27, 2017    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: March 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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