Laryngologic Surgical ProceduresNCT03091179
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery
A study testing THRIVE and Endotracheal tube in people with Laryngologic Surgical Procedures, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laryngologic Surgical Procedures
- 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
- 17 Mar 2017to 18 Jul 2018
- 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 short, non-laser laryngologic 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Laryngologic Surgical Procedures.
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).
- Conditions
- Laryngologic Surgical Procedures
- Being tested
- THRIVE, Endotracheal tube
- Keywords
- airway management, high flow nasal oxygen, high flow nasal cannula, 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
a plastic tube for mechanical ventilation
| 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.
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
Measured: intraoperative (up to one hour)
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
time from end of surgery to responding to commands/extubation
Measured: intraoperative (up to 20 min)
Suspension Time (Primary Surgical Outcome)
Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
Measured: intraoperative (up to 5 min)
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
Measured: intraoperative (up to 5 min)
Duration of Surgery (Primary Surgical Outcome)
Measured: intraoperative (up to one hour)
Secondary outcomes (6)
Alertness
Time required for the patient to become fully alert and oriented per standard recovery room evaluation
Measured: Recovery room admission (up to 30 min following admission to recovery room)
Recovery Room Time
Measured: Up to 2 hours after procedure
Numerical Pain Rating Scores
A score from 0 to 10, higher scores corresponding to higher pain
Measured: Recovery room admission and discharge (up to 2 hours)
Opioid Consumption
Total oral opioid consumption in morphine milligram equivalents
Measured: Recovery room admission and discharge (up to 2 hours)
Change in Voice Handicap Index (VHI)
numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome
Measured: Preoperative assessment and one month after surgery
Quality of Recovery
15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start17 Mar 2017
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngologic 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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Nekhendzy, Stanford University
- Investigators
- Vladimir Nekhendzy, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091179
- Sponsor's protocol ID
- 39202
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2017
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.
PubMed 32078170
Study at a glance
From the registry record, last updated by the sponsor on 4 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 Short Laryngologic Surgical Procedures.
- ClinicalTrials.gov ID
- NCT03091179
- Acronym / sponsor ID
- 39202
- Conditions
- Laryngologic Surgical Procedures
- Keywords
- airway management, high flow nasal oxygen, high flow nasal cannula, THRIVE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 short, non-laser laryngologic surgery
Key exclusion criteria (13 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 tubea plastic tube for mechanical ventilation | Device | Endotracheal tube |
Primary outcome
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
Time frame: intraoperative (up to one hour)
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
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
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
Duration of Surgery (Primary Surgical Outcome)
Time frame: intraoperative (up to one hour)
6 secondary outcomes
Alertness
Time frame: Recovery room admission (up to 30 min following admission to recovery room)
Recovery Room Time
Time frame: Up to 2 hours after procedure
Numerical Pain Rating Scores
Time frame: Recovery room admission and discharge (up to 2 hours)
Opioid Consumption
Time frame: Recovery room admission and discharge (up to 2 hours)
Change in Voice Handicap Index (VHI)
Time frame: Preoperative assessment and one month after surgery
Quality of Recovery
Time frame: One week after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32078170Nekhendzy V, Saxena A, Mittal B, Sun E, Sung K, Dewan K, Damrose EJ. The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery. Laryngoscope. 2020 Dec;130(12):E874-E881. doi: 10.1002/lary.28562. Epub 2020 Feb 20.
- Individual participant dataSharing planned: No
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 Laryngologic Surgical Procedures, 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 13 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 4 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 Jul 2019). 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?
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) (time frame: intraoperative (up to one hour)). The study lists 5 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 NCT03091179, which also lists 1 linked publication.
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 4 Mar 2020.