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CompletedNCT03086265Updated Mar 17, 2020Results posted

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

An interventional study of THRIVE and Endotracheal tube in Otorhinolaryngologic Surgical Procedures and Laser Therapy, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Otorhinolaryngologic Surgical Procedures
  • Laser Therapy

Keywords

  • airway management
  • high flow nasal oxygen high flow nasal cannula THRIVE
  • high flow nasal cannula THRIVE
  • THRIVE
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients presenting for laser laryngeal surgery

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    THRIVE

    high flow nasal oxygen

    Device: THRIVE

  • Active comparator
    Endotracheal tube

    tracheal intubation

    Device: Endotracheal tube

Interventions

  • DeviceTHRIVE

    active nasal oxygen delivery system

  • DeviceEndotracheal tube

    Plastic tube for supporting ventilation during surgery

06

What researchers measure

Primary outcomes

  1. Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

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

    Time frame: Duration of surgery (average approximately 1 hour)

  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

    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.

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

  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)

    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).

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

  8. 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.

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

  9. 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).

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

  10. Awakening/Extubation Time

    Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.

    Time frame: Duration of surgery (average approximately 1 hour)

  11. Time to Suspension

    Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.

    Time frame: Duration of surgery (average approximately 1 hour)

  12. Number of Suspension Adjustments

    Number of adjustments of the suspension laryngoscope.

    Time frame: Duration of surgery (average approximately 1 hour)

  13. 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.

    Time frame: Duration of surgery (average approximately 1 hour)

Secondary outcomes

  1. Count of Participants Requiring Jet Ventilation

    Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.

    Time frame: Duration of surgery (average approximately 1 hour)

  2. Time to Spontaneous Ventilation

    Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.

    Time frame: Duration of surgery (average approximately 1 hour)

  3. Apnea Time

    Recorded from induction of anesthesia to the return of spontaneous ventilation.

    Time frame: Duration of surgery (average approximately 1 hour)

  4. Duration of Anesthesia

    Recorded from induction of anesthesia to patient's awakening/extubation

    Time frame: Duration of surgery (average approximately 1 hour)

  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

    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.

    Time frame: Duration of surgery (average approximately 1 hour)

  11. Recovery Room Discharge-ready Time

    From admission to recovery room, to discharge from recovery room

    Time frame: Duration of recovery room stay (average approximately 1 hour)

  12. First Pain Score in Recovery Room

    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

    Time frame: Duration of recovery room stay (average approximately 1 hour)

  13. Pain Score at Discharge From Recovery Room

    Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

    Time frame: Duration of recovery room stay (average approximately 1 hour)

  14. Analgesic Consumption

    Analgesic consumption was measured in oral morphine milligram equivalents (MME)

    Time frame: Recovery room to 7th postoperative day

  15. Quality of Recovery (QoR)15 Score

    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.

    Time frame: Prior to procedure, and 1-2 hours after procedure

07

Results

Posted Mar 17, 2020

Participant flow

Participant flow — Overall Study
MilestoneTHRIVEEndotracheal Tube
Started1010
Completed1010
Not completed00

Outcome measures

PrimaryLowest Intraoperative Peripheral Oxygen Saturation (SpO2)

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

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · percentage of oxygen
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
percentage of oxygenTHRIVEEndotracheal Tube
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)97 ± 297 ± 3
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.7934
PrimaryPartial 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)
Reported as:
Mean · mmHg
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
mmHgTHRIVE
Induction365 ± 40
10 minutes post-induction294 ± 79
20 minutes post-induction279 ± 81
30 minutes post-induction245 ± 81
40 minutes post-induction223 ± 67
Spontaneous ventilation251 ± 102
Recovery room86 ± 13
PrimaryPartial 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)
Reported as:
Mean · mmHg
Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)
mmHgTHRIVE
Induction32 ± 5
10 minutes post-induction54 ± 5
20 minutes post-induction65 ± 9
30 minutes post-induction77 ± 8
40 minutes post-induction86 ± 7
Spontaneous ventilation71 ± 13
Recovery room37 ± 5
PrimarypH 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.

Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Reported as:
Mean · pH
pH in Blood
pHTHRIVE
Induction7.4 ± 0
10 minutes post-induction7.2 ± 0
20 minutes post-induction7.2 ± 0
30 minutes post-induction7.1 ± 0
40 minutes post-induction7.1 ± 0.1
Spontaneous ventilation7.4 ± 0.1
Recovery room7.4 ± 0
PrimaryHeart Rate
Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Reported as:
Mean · beats per minute
Heart Rate
beats per minuteTHRIVEEndotracheal Tube
Induction65 ± 1170 ± 15
10 minutes post-induction72 ± 1281 ± 14
20 minutes post-induction79 ± 1379 ± 9
30 minutes post-induction79 ± 1476 ± 12
40 minutes post-induction81 ± 1573 ± 9
Spontaneous ventilation72 ± 1471 ± 15
PrimaryMean Arterial Pressure (MAP)
Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Reported as:
Mean · mmHg
Mean Arterial Pressure (MAP)
mmHgTHRIVEEndotracheal Tube
Induction90 ± 1692 ± 12
10 minutes post-induction78 ± 1276 ± 9
20 minutes post-induction71 ± 983 ± 17
30 minutes post-induction72 ± 1285 ± 13
40 minutes post-induction69 ± 1380 ± 12
Spontaneous ventilation88 ± 1488 ± 18
PrimaryStroke 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).

Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Reported as:
Mean · ml/b/m^2
Stroke Volume Index (SVI)
ml/b/m^2THRIVEEndotracheal Tube
Induction50 ± 1048 ± 13
10 minutes post-induction45 ± 736 ± 7
20 minutes post-induction48 ± 1035 ± 6
30 minutes post-induction51 ± 1239 ± 9
40 minutes post-induction52 ± 643 ± 10
Spontaneous ventilation54 ± 1753 ± 12
PrimaryCardiac 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.

Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Reported as:
Mean · L/min/m^2
Cardiac Index (CI)
L/min/m^2THRIVEEndotracheal Tube
Induction3.2 ± 0.73.4 ± 0.9
10 minutes post-induction3.2 ± 0.73.0 ± 0.7
20 minutes post-induction3.7 ± 0.52.8 ± 0.5
30 minutes post-induction3.9 ± 0.73.0 ± 0.6
40 minutes post-induction4.2 ± 0.83.1 ± 0.7
Spontaneous ventilation3.7 ± 0.93.6 ± 0.6
PrimarySystemic 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).

Time frame:
Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Reported as:
Mean · dynes*s/cm^5/m^2
Systemic Vascular Resistance Index (SVRI)
dynes*s/cm^5/m^2THRIVEEndotracheal Tube
Induction2249 ± 6522140 ± 443
10 minutes post-induction1769 ± 5492026 ± 446
20 minutes post-induction1341 ± 3212182 ± 440
30 minutes post-induction1330 ± 4642080 ± 446
40 minutes post-induction1130 ± 2171187 ± 530
Spontaneous ventilation1841 ± 4432152 ± 578
PrimaryAwakening/Extubation Time

Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Awakening/Extubation Time
minutesTHRIVEEndotracheal Tube
Awakening/Extubation Time14 ± 313 ± 6
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.6876
PrimaryTime to Suspension

Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Time to Suspension
minutesTHRIVEEndotracheal Tube
Time to Suspension4 ± 23 ± 2
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.7549
PrimaryNumber of Suspension Adjustments

Number of adjustments of the suspension laryngoscope.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · adjustments
Number of Suspension Adjustments
adjustmentsTHRIVEEndotracheal Tube
Number of Suspension Adjustments1 ± 12 ± 4
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.6479
PrimaryDuration 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.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Duration of Surgery
minutesTHRIVEEndotracheal Tube
Duration of Surgery61 ± 2957 ± 44
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.8322
SecondaryCount of Participants Requiring Jet Ventilation

Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Count of participants · Participants
Count of Participants Requiring Jet Ventilation
ParticipantsTHRIVEEndotracheal Tube
Count of Participants Requiring Jet Ventilation70
SecondaryTime to Spontaneous Ventilation

Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Time to Spontaneous Ventilation
minutesTHRIVEEndotracheal Tube
Time to Spontaneous Ventilation5 ± 411 ± 5
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.0058
SecondaryApnea Time

Recorded from induction of anesthesia to the return of spontaneous ventilation.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Apnea Time
minutesTHRIVEEndotracheal Tube
Apnea Time70 ± 2887 ± 48
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.3346
SecondaryDuration of Anesthesia

Recorded from induction of anesthesia to patient's awakening/extubation

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Duration of Anesthesia
minutesTHRIVEEndotracheal Tube
Duration of Anesthesia78 ± 2889 ± 48
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.5513
SecondaryTotal Propofol Dose (Anesthetic)
Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · mg
Total Propofol Dose (Anesthetic)
mgTHRIVEEndotracheal Tube
Total Propofol Dose (Anesthetic)730 ± 288920 ± 388
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.1927
SecondaryTotal Remifentanil Dose (Anesthetic)
Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · µg
Total Remifentanil Dose (Anesthetic)
µgTHRIVEEndotracheal Tube
Total Remifentanil Dose (Anesthetic)996 ± 6741114 ± 432
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.6483
SecondaryTotal Phenylephrine Dose (Vasoactive Drug)
Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · mg
Total Phenylephrine Dose (Vasoactive Drug)
mgTHRIVEEndotracheal Tube
Total Phenylephrine Dose (Vasoactive Drug)300 ± 591479 ± 757
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.5625
SecondaryTotal Ephedrine Dose (Vasoactive Drug)
Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · mg
Total Ephedrine Dose (Vasoactive Drug)
mgTHRIVEEndotracheal Tube
Total Ephedrine Dose (Vasoactive Drug)4 ± 81 ± 2
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.2827
SecondaryTotal Labetalol Dose (Vasoactive Drug)
Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · mg
Total Labetalol Dose (Vasoactive Drug)
mgTHRIVEEndotracheal Tube
Total Labetalol Dose (Vasoactive Drug)15 ± 2213 ± 21
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.8426
SecondaryTime to Patient Being Alert and Oriented x 4

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.

Time frame:
Duration of surgery (average approximately 1 hour)
Reported as:
Mean · minutes
Time to Patient Being Alert and Oriented x 4
minutesTHRIVEEndotracheal Tube
Time to Patient Being Alert and Oriented x 423 ± 2923 ± 19
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.9856
SecondaryRecovery Room Discharge-ready Time

From admission to recovery room, to discharge from recovery room

Time frame:
Duration of recovery room stay (average approximately 1 hour)
Reported as:
Mean · minutes
Recovery Room Discharge-ready Time
minutesTHRIVEEndotracheal Tube
Recovery Room Discharge-ready Time64 ± 1862 ± 12
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.8112
SecondaryFirst Pain Score in Recovery Room

Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

Time frame:
Duration of recovery room stay (average approximately 1 hour)
Reported as:
Mean · score on a scale
First Pain Score in Recovery Room
score on a scaleTHRIVEEndotracheal Tube
First Pain Score in Recovery Room2 ± 43 ± 3
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.6587
SecondaryPain Score at Discharge From Recovery Room

Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).

Time frame:
Duration of recovery room stay (average approximately 1 hour)
Reported as:
Mean · score on a scale
Pain Score at Discharge From Recovery Room
score on a scaleTHRIVEEndotracheal Tube
Pain Score at Discharge From Recovery Room3 ± 22 ± 2
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.4143
SecondaryAnalgesic Consumption

Analgesic consumption was measured in oral morphine milligram equivalents (MME)

Time frame:
Recovery room to 7th postoperative day
Reported as:
Mean · MME
Analgesic Consumption
MMETHRIVEEndotracheal Tube
Analgesic Consumption12 ± 178 ± 7
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.4324
SecondaryQuality of Recovery (QoR)15 Score

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.

Time frame:
Prior to procedure, and 1-2 hours after procedure
Reported as:
Mean · score on a scale
Quality of Recovery (QoR)15 Score
score on a scaleTHRIVEEndotracheal Tube
Preoperative135 ± 17138 ± 8
Postoperative146 ± 5136 ± 11
Statistical analysis
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.7221
  • THRIVE vs Endotracheal Tube · t-test, 2 sided · p = 0.0336

Adverse events

Collected over Up to 1 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
THRIVE0/10 (0%)0/10 (0%)0/10 (0%)
Endotracheal Tube0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)THRIVEEndotracheal TubeTotal
Mean53 ± 1552 ± 1253 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)THRIVEEndotracheal TubeTotal
Female8614
Male246
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)THRIVEEndotracheal TubeTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)THRIVEEndotracheal TubeTotal
United States101020
08

Study locations

1 site
  • Stanford Hospital and Clinics
    Stanford, California 94305, United States
09

References and documents

Study documents

  • Study protocol · Aug 12, 2016
  • Statistical analysis plan · Feb 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03086265
Lead sponsor
Stanford University
Responsible party
Vladimir Nekhendzy (Clinical Professor of Anesthesiology and Otolaryngology, Stanford University) — Principal investigator
First posted
Mar 22, 2017
Start date
Mar 24, 2017
Primary completion
Feb 26, 2019
Completion
Feb 26, 2019
Results posted
Mar 17, 2020
Last update
Mar 17, 2020

Study contacts

Vladimir Nekhendzy, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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