Otorhinolaryngologic Surgical ProceduresNCT03086265

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

A study testing THRIVE and Endotracheal tube in people with Otorhinolaryngologic Surgical Procedures and Laser Therapy, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Otorhinolaryngologic Surgical Procedures, Laser Therapy
What is being tested?: THRIVE and Endotracheal tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 24 Mar 2017to 26 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients presenting for laser laryngeal surgery

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Hospital and Clinics
Stanford, California, 94305

Other trials in United States

About this study

Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for 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).

Conditions: Otorhinolaryngologic Surgical Procedures, Laser Therapy
Being tested: THRIVE, Endotracheal tube
Keywords: airway management, high flow nasal oxygen high flow nasal cannula THRIVE, high flow nasal cannula THRIVE, THRIVE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THRIVEDevice
active nasal oxygen delivery system
Endotracheal tubeDevice
Plastic tube for supporting ventilation during surgery

Study groups in NCT03086265
Study group	Role	What they receive
THRIVE	Experimental	high flow nasal oxygen Receives: Device: THRIVE
Endotracheal tube	Active comparator	tracheal intubation Receives: Device: Endotracheal tube

What is being measured

The primary outcome is the main question the study is designed to answer.

Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Measured: Duration of surgery (average approximately 1 hour)
Partial Pressure of Oxygen in the Arterial Blood (PaO2)
Measured: 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)
Measured: 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.
Measured: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Heart Rate
Measured: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Mean Arterial Pressure (MAP)
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Duration of surgery (average approximately 1 hour)
Number of Suspension Adjustments
Number of adjustments of the suspension laryngoscope.
Measured: 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.
Measured: Duration of surgery (average approximately 1 hour)

Secondary outcomes (15)

Count of Participants Requiring Jet Ventilation
Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Measured: Duration of surgery (average approximately 1 hour)
Time to Spontaneous Ventilation
Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
Measured: Duration of surgery (average approximately 1 hour)
Apnea Time
Recorded from induction of anesthesia to the return of spontaneous ventilation.
Measured: Duration of surgery (average approximately 1 hour)
Duration of Anesthesia
Recorded from induction of anesthesia to patient's awakening/extubation
Measured: Duration of surgery (average approximately 1 hour)
Total Propofol Dose (Anesthetic)
Measured: Duration of surgery (average approximately 1 hour)
Total Remifentanil Dose (Anesthetic)
Measured: Duration of surgery (average approximately 1 hour)
Total Phenylephrine Dose (Vasoactive Drug)
Measured: Duration of surgery (average approximately 1 hour)
Total Ephedrine Dose (Vasoactive Drug)
Measured: Duration of surgery (average approximately 1 hour)
Total Labetalol Dose (Vasoactive Drug)
Measured: Duration of surgery (average approximately 1 hour)
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.
Measured: Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time
From admission to recovery room, to discharge from recovery room
Measured: Duration of recovery room stay (average approximately 1 hour)
First Pain Score in Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Measured: Duration of recovery room stay (average approximately 1 hour)
Pain Score at Discharge From Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Measured: Duration of recovery room stay (average approximately 1 hour)
Analgesic Consumption
Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Measured: Recovery room to 7th postoperative day
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.
Measured: Prior to procedure, and 1-2 hours after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 201726 Feb 2019

First posted22 Mar 2017
Study start24 Mar 2017
Primary completion26 Feb 2019
Study completion26 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Otorhinolaryngologic Surgical ProceduresStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03086265
Sponsor's protocol ID: 36060
Status last verified: Mar 2020
First submitted: 5 Mar 2017
Last updated: 17 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 2
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RecruitingPhase 3
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All Otorhinolaryngologic Surgical Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Laser Laryngeal Surgery
ClinicalTrials.gov ID: NCT03086265
Acronym / sponsor ID: 36060
Conditions: Otorhinolaryngologic Surgical Procedures, Laser Therapy
Keywords: airway management, high flow nasal oxygen high flow nasal cannula THRIVE, high flow nasal cannula THRIVE, THRIVE
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 24 Mar 2017 (actual)
Primary completion: 26 Feb 2019 (actual)
Study completion: 26 Feb 2019 (actual)
First posted: 22 Mar 2017 (actual)
Results: Posted 17 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
THRIVE	Experimental	Device: THRIVEhigh flow nasal oxygen
Endotracheal tube	Active comparator	Device: Endotracheal tubetracheal intubation

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients presenting for laser laryngeal surgery

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THRIVEactive nasal oxygen delivery system	Device	THRIVE
Endotracheal tubePlastic tube for supporting ventilation during surgery	Device	Endotracheal tube

Primary outcome

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.
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)
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)
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.
Heart Rate
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Mean Arterial Pressure (MAP)
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
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).
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.
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).
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.
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.
Number of Suspension Adjustments
Time frame: Duration of surgery (average approximately 1 hour)
Number of adjustments of the suspension laryngoscope.
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.

15 secondary outcomes

Count of Participants Requiring Jet Ventilation
Time frame: Duration of surgery (average approximately 1 hour)
Time to Spontaneous Ventilation
Time frame: Duration of surgery (average approximately 1 hour)
Apnea Time
Time frame: Duration of surgery (average approximately 1 hour)
Duration of Anesthesia
Time frame: Duration of surgery (average approximately 1 hour)
Total Propofol Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
Total Remifentanil Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
Total Phenylephrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Total Ephedrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Total Labetalol Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Time to Patient Being Alert and Oriented x 4
Time frame: Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time
Time frame: Duration of recovery room stay (average approximately 1 hour)
First Pain Score in Recovery Room
Time frame: Duration of recovery room stay (average approximately 1 hour)
Pain Score at Discharge From Recovery Room
Time frame: Duration of recovery room stay (average approximately 1 hour)
Analgesic Consumption
Time frame: Recovery room to 7th postoperative day
Quality of Recovery (QoR)15 Score
Time frame: Prior to procedure, and 1-2 hours after procedure

Results and safety

Results posted to the registry on 17 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
THRIVE	10	10
Endotracheal Tube	10	10

Primary outcome: Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

Time frame: Duration of surgery (average approximately 1 hour). Mean (Standard Deviation). Unit: percentage of oxygen

Measure	THRIVE n = 10	Endotracheal Tube n = 10
Value	97 (2)	97 (3)

THRIVE vs Endotracheal Tube: p = 0.7934, t-test, 2 sided

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	THRIVE n = 10
Induction	365 (40)
10 minutes post-induction	294 (79)
20 minutes post-induction	279 (81)
30 minutes post-induction	245 (81)
40 minutes post-induction	223 (67)
Spontaneous ventilation	251 (102)
Recovery room	86 (13)

Population analysed: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	THRIVE n = 10
Induction	32 (5)
10 minutes post-induction	54 (5)
20 minutes post-induction	65 (9)
30 minutes post-induction	77 (8)
40 minutes post-induction	86 (7)
Spontaneous ventilation	71 (13)
Recovery room	37 (5)

Population analysed: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

Primary outcome: pH in Blood

Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour). Mean (Standard Deviation). Unit: pH

Measure	THRIVE n = 10
Induction	7.4 (0)
10 minutes post-induction	7.2 (0)
20 minutes post-induction	7.2 (0)
30 minutes post-induction	7.1 (0)
40 minutes post-induction	7.1 (0.1)
Spontaneous ventilation	7.4 (0.1)
Recovery room	7.4 (0)

Population analysed: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
THRIVE	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Endotracheal Tube	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Otorhinolaryngologic Surgical Procedures

Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vladimir Nekhendzy, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing THRIVE and Endotracheal tube in people with Otorhinolaryngologic Surgical Procedures and Laser Therapy, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) (time frame: Duration of surgery (average approximately 1 hour)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03086265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.