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The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE | Experimental | high flow nasal oxygen |
|
| endotracheal tube or supraglottic airway | Active Comparator | tracheal intubation or supraglottic airway device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVE | Device | active nasal oxygen delivery system |
| |
| Endotracheal tube or Supraglottic airway |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood. | Duration of surgery (average 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. | Duration of surgery (average approximately 1 hour) |
| Time to Bronchoscope Placement in Trachea | Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement. | Duration of surgery (average approximately 1 hour) |
| Number of Tracheal Bronchoscope Placements Required | Duration of surgery (average approximately 1 hour) | |
| Duration of Procedure | Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure. | Duration of surgery (average approximately 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Patient Being Alert and Oriented x 4 | Recorded from patient's admission to the post-anesthesia care unit (PACU) to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse. | Duration of surgery (average approximately 1 hour) |
| Recovery Room Discharge-ready Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Nekhendzy, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | THRIVE | Participants receive Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) active nasal oxygen delivery system. |
| FG001 | Endotracheal Tube or Supraglottic Airway | Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THRIVE | Participants receive THRIVE active nasal oxygen delivery system. |
| BG001 | Endotracheal Tube or Supraglottic Airway | Participants receive tracheal intubation or supraglottic airway device for mechanical 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 | Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood. | Posted | Mean | Standard Deviation | percentage of oxygen | Duration of surgery (average approximately 1 hour) |
|
Up to 1 week
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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 | Participants receive THRIVE active nasal oxygen delivery system. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Nekhendzy, M.D., FASA | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2017 | Jun 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2020 | Jun 10, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Device |
Plastic devices for mechanical ventilation |
|
From admission to recovery room, to discharge from recovery room |
| Duration of recovery room stay (average approximately 1 hour) |
| First Pain Score in Recovery Room | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Duration of recovery room stay (average approximately 1 hour) |
| Discharge-ready Pain Score | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Day of discharge (up to 2 minutes) |
| Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | Recovery room to 7th postoperative day |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Awakening/Extubation Time | Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Primary | Time to Bronchoscope Placement in Trachea | Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Primary | Number of Tracheal Bronchoscope Placements Required | Posted | Mean | Standard Deviation | placements | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Primary | Duration of Procedure | Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Time to Patient Being Alert and Oriented x 4 | Recorded from patient's admission to the post-anesthesia care unit (PACU) to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Recovery Room Discharge-ready Time | From admission to recovery room, to discharge from recovery room | Posted | Mean | Standard Deviation | minutes | Duration of recovery room stay (average approximately 1 hour) |
|
|
|
|
| Secondary | First Pain Score in Recovery Room | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Duration of recovery room stay (average approximately 1 hour) |
|
|
|
|
| Secondary | Discharge-ready Pain Score | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Day of discharge (up to 2 minutes) |
|
|
|
|
| Secondary | Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | Posted | Mean | Standard Deviation | MME | Recovery room to 7th postoperative day |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Endotracheal Tube or Supraglottic Airway | Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation. | 0 | 10 | 0 | 10 | 0 | 10 |
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