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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE | Experimental | high flow nasal oxygen |
|
| Endotracheal tube | Active Comparator | tracheal intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE | Device | active nasal oxygen delivery system |
| |
| Endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) | intraoperative (up to one hour) | |
| Time to Awakening From Anesthesia (Primary Anesthesia Outcome) | time from end of surgery to responding to commands/extubation | 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 | 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 | intraoperative (up to 5 min) |
| Duration of Surgery (Primary Surgical Outcome) | intraoperative (up to one hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Alertness | Time required for the patient to become fully alert and oriented per standard recovery room evaluation | Recovery room admission (up to 30 min following admission to recovery room) |
| Recovery Room Time |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Nekhendzy, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32078170 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | THRIVE | THRIVE: active nasal oxygen delivery system |
| FG001 | Control Group | Endotracheal tube or Supraglottic jet ventilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THRIVE | THRIVE: active nasal oxygen delivery system |
| BG001 | Control Group | Endotracheal tube or Supraglottic jet ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) | Posted | Mean | Standard Deviation | percentage of saturation (SpO2) | intraoperative (up to one hour) |
|
|
one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THRIVE | THRIVE: active nasal oxygen delivery system | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Nekhendzy | Stanford University | 650-498-4055 | nek@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2019 | Jun 20, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 15, 2017 | Jun 21, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Device |
a plastic tube for mechanical ventilation |
|
| Up to 2 hours after procedure |
| Numerical Pain Rating Scores | A score from 0 to 10, higher scores corresponding to higher pain | Recovery room admission and discharge (up to 2 hours) |
| Opioid Consumption | Total oral opioid consumption in morphine milligram equivalents | 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 | 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. | One week after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Time to Awakening From Anesthesia (Primary Anesthesia Outcome) | time from end of surgery to responding to commands/extubation | Posted | Mean | Standard Deviation | minutes | intraoperative (up to 20 min) |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | minutes | intraoperative (up to 5 min) |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | maneuvers | intraoperative (up to 5 min) |
|
|
|
| Primary | Duration of Surgery (Primary Surgical Outcome) | Posted | Mean | Standard Deviation | minutes | intraoperative (up to one hour) |
|
|
|
| Secondary | Alertness | Time required for the patient to become fully alert and oriented per standard recovery room evaluation | Posted | Mean | Standard Deviation | minutes | Recovery room admission (up to 30 min following admission to recovery room) |
|
|
|
| Secondary | Recovery Room Time | Posted | Mean | Standard Deviation | minutes | Up to 2 hours after procedure |
|
|
|
| Secondary | Numerical Pain Rating Scores | A score from 0 to 10, higher scores corresponding to higher pain | Posted | Mean | Standard Deviation | score on a scale | Recovery room admission and discharge (up to 2 hours) |
|
|
|
| Secondary | Opioid Consumption | Total oral opioid consumption in morphine milligram equivalents | Posted | Mean | Standard Deviation | MME: morphine milligram equivalents | Recovery room admission and discharge (up to 2 hours) |
|
|
|
| Secondary | Change in Voice Handicap Index (VHI) | numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome | Posted | Mean | Standard Deviation | score on a scale | Preoperative assessment and one month after surgery |
|
|
|
| Secondary | Quality of Recovery | 15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome. | Posted | Mean | Standard Deviation | score on a scale | One week after surgery |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control Group | Endotracheal tube or Supraglottic jet ventilation | 0 | 10 | 0 | 10 | 0 | 10 |
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