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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).
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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 |
|---|---|---|
| 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) |
| Partial Pressure of Oxygen in the Arterial Blood (PaO2) | 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) | 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. | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour) |
| Heart Rate | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) | |
| Mean Arterial Pressure (MAP) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Requiring Jet Ventilation | Jet ventilation refers to delivery of oxygen via high pressure jet ventilator. | Duration of surgery (average approximately 1 hour) |
| Time to Spontaneous Ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | THRIVE | Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). |
| FG001 | Endotracheal Tube | Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THRIVE | Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). |
| BG001 | Endotracheal Tube | Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery). |
| 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 received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). |
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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 | Aug 12, 2016 | Feb 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2020 | Feb 24, 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 tube for supporting ventilation during surgery |
|
| 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. | 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). | 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. | 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. | Duration of surgery (average approximately 1 hour) |
| Number of Suspension Adjustments | Number of adjustments of the suspension laryngoscope. | 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. | Duration of surgery (average approximately 1 hour) |
Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
| Duration of surgery (average approximately 1 hour) |
| Apnea Time | Recorded from induction of anesthesia to the return of spontaneous ventilation. | Duration of surgery (average approximately 1 hour) |
| Duration of Anesthesia | Recorded from induction of anesthesia to patient's awakening/extubation | Duration of surgery (average approximately 1 hour) |
| Total Propofol Dose (Anesthetic) | Duration of surgery (average approximately 1 hour) |
| Total Remifentanil Dose (Anesthetic) | Duration of surgery (average approximately 1 hour) |
| Total Phenylephrine Dose (Vasoactive Drug) | Duration of surgery (average approximately 1 hour) |
| Total Ephedrine Dose (Vasoactive Drug) | Duration of surgery (average approximately 1 hour) |
| Total Labetalol Dose (Vasoactive Drug) | 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. | Duration of surgery (average approximately 1 hour) |
| Recovery Room Discharge-ready Time | 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 scale was 0-10 (0 = no pain, 10 - worst pain imaginable). | 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). | Duration of recovery room stay (average approximately 1 hour) |
| Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | 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. | Prior to procedure, and 1-2 hours after procedure |
| 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 | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | mmHg | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour) |
|
|
|
| Primary | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | mmHg | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour) |
|
|
|
| Primary | 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. | This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | pH | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour) |
|
|
|
| Primary | Heart Rate | Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | beats per minute | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) |
|
|
|
| Primary | Mean Arterial Pressure (MAP) | Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | mmHg | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) |
|
|
|
| Primary | 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). | Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | ml/b/m^2 | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) |
|
|
|
| Primary | 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. | Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | L/min/m^2 | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) |
|
|
|
| Primary | 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). | Participants with measurements at each respective time point are included in the analysis. | Posted | Mean | Standard Deviation | dynes*s/cm^5/m^2 | Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour) |
|
|
|
| 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 Suspension | Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Primary | Number of Suspension Adjustments | Number of adjustments of the suspension laryngoscope. | Posted | Mean | Standard Deviation | adjustments | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Count of Participants Requiring Jet Ventilation | Jet ventilation refers to delivery of oxygen via high pressure jet ventilator. | Posted | Count of Participants | Participants | Duration of surgery (average approximately 1 hour) |
|
|
|
| Secondary | Time to Spontaneous Ventilation | Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Apnea Time | Recorded from induction of anesthesia to the return of spontaneous ventilation. | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Duration of Anesthesia | Recorded from induction of anesthesia to patient's awakening/extubation | Posted | Mean | Standard Deviation | minutes | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Total Propofol Dose (Anesthetic) | Posted | Mean | Standard Deviation | mg | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Total Remifentanil Dose (Anesthetic) | Posted | Mean | Standard Deviation | µg | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Total Phenylephrine Dose (Vasoactive Drug) | Participants who received phenylephrine are included in the analysis. | Posted | Mean | Standard Deviation | mg | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Total Ephedrine Dose (Vasoactive Drug) | Participants who received ephedrine are included in the analysis. | Posted | Mean | Standard Deviation | mg | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | Total Labetalol Dose (Vasoactive Drug) | Participants who received labetalol are included in the analysis. | Posted | Mean | Standard Deviation | mg | Duration of surgery (average approximately 1 hour) |
|
|
|
|
| Secondary | 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. | 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 scale was 0-10 (0 = no pain, 10 - worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Duration of recovery room stay (average approximately 1 hour) |
|
|
|
|
| Secondary | Pain Score at Discharge From Recovery Room | Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | Duration of recovery room stay (average approximately 1 hour) |
|
|
|
|
| Secondary | Analgesic Consumption | Analgesic consumption was measured in oral morphine milligram equivalents (MME) | Posted | Mean | Standard Deviation | MME | Recovery room to 7th postoperative day |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Prior to procedure, and 1-2 hours after procedure |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Endotracheal Tube | Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery). | 0 | 10 | 0 | 10 | 0 | 10 |
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|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| Recovery room |
|
|
|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| Recovery room |
|
|
|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| Recovery room |
|
|
| 10 minutes post-induction |
|
|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| 10 minutes post-induction |
|
|
| 20 minutes post-induction |
|
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| 30 minutes post-induction |
|
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| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| 10 minutes post-induction |
|
|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| 10 minutes post-induction |
|
|
| 20 minutes post-induction |
|
|
| 30 minutes post-induction |
|
|
| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| 10 minutes post-induction |
|
|
| 20 minutes post-induction |
|
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| 30 minutes post-induction |
|
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| 40 minutes post-induction |
|
|
| Spontaneous ventilation |
|
|
| 0.0336 |
| Other |