Laser Therapy, Otorhinolaryngologic Surgical Procedures
Conditions
Keywords
airway management, high flow nasal oxygen high flow nasal cannula THRIVE, high flow nasal cannula THRIVE, THRIVE
Brief summary
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).
Interventions
DEVICETHRIVE
active nasal oxygen delivery system
DEVICEEndotracheal tube
Plastic tube for supporting ventilation during surgery
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting for laser laryngeal surgery
Exclusion criteria
1. Patients with significantly decreased myocardial function (ejection fraction \< 50%) 2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions. 3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication. 4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs) . 5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2. 6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range. 7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes). 8. Patients with skull base defects. 9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range. 10. 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% . 11. Obese patients with BMI \> 35 kg/m2. 12. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment. 13. Patients with hiatal hernia and full stomach patients. 14. Patient's refusal to participate in the study. 15. Patients who do not understand English or mentally handicapped. Pregnant or breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | 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) | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 | Duration of surgery (average approximately 1 hour) | Number of adjustments of the suspension laryngoscope. |
| Duration of Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Consumption | Recovery room to 7th postoperative day | Analgesic consumption was measured in oral morphine milligram equivalents (MME) |
| Count of Participants Requiring Jet Ventilation | Duration of surgery (average approximately 1 hour) | Jet ventilation refers to delivery of oxygen via high pressure jet ventilator. |
| Quality of Recovery (QoR)15 Score | Prior to procedure, and 1-2 hours after procedure | 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. |
| Time to Spontaneous Ventilation | Duration of surgery (average approximately 1 hour) | Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation. |
| Apnea Time | Duration of surgery (average approximately 1 hour) | Recorded from induction of anesthesia to the return of spontaneous ventilation. |
| Duration of Anesthesia | Duration of surgery (average approximately 1 hour) | Recorded from induction of anesthesia to patient's awakening/extubation |
| 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 | Duration of surgery (average approximately 1 hour) | 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. |
| Recovery Room Discharge-ready Time | Duration of recovery room stay (average approximately 1 hour) | From admission to recovery room, to discharge from recovery room |
| First Pain Score in Recovery Room | Duration of recovery room stay (average approximately 1 hour) | Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable). |
| Pain Score at Discharge From Recovery Room | Duration of recovery room stay (average approximately 1 hour) | Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THRIVE Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). | 10 |
| Endotracheal Tube Participants received tracheal intubation (endotracheal tube: Plastic tube for supporting ventilation during surgery). | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Endotracheal Tube | Total | THRIVE |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 13 | 53 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Awakening/Extubation Time | 14 minutes | Standard Deviation 3 |
| Endotracheal Tube | Awakening/Extubation Time | 13 minutes | Standard Deviation 6 |
p-value: 0.6876t-test, 2 sided
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.
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Population: Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Cardiac Index (CI) | Induction | 3.2 L/min/m^2 | Standard Deviation 0.7 |
| THRIVE | Cardiac Index (CI) | 10 minutes post-induction | 3.2 L/min/m^2 | Standard Deviation 0.7 |
| THRIVE | Cardiac Index (CI) | 20 minutes post-induction | 3.7 L/min/m^2 | Standard Deviation 0.5 |
| THRIVE | Cardiac Index (CI) | 30 minutes post-induction | 3.9 L/min/m^2 | Standard Deviation 0.7 |
| THRIVE | Cardiac Index (CI) | 40 minutes post-induction | 4.2 L/min/m^2 | Standard Deviation 0.8 |
| THRIVE | Cardiac Index (CI) | Spontaneous ventilation | 3.7 L/min/m^2 | Standard Deviation 0.9 |
| Endotracheal Tube | Cardiac Index (CI) | 40 minutes post-induction | 3.1 L/min/m^2 | Standard Deviation 0.7 |
| Endotracheal Tube | Cardiac Index (CI) | Induction | 3.4 L/min/m^2 | Standard Deviation 0.9 |
| Endotracheal Tube | Cardiac Index (CI) | 30 minutes post-induction | 3.0 L/min/m^2 | Standard Deviation 0.6 |
| Endotracheal Tube | Cardiac Index (CI) | 10 minutes post-induction | 3.0 L/min/m^2 | Standard Deviation 0.7 |
| Endotracheal Tube | Cardiac Index (CI) | Spontaneous ventilation | 3.6 L/min/m^2 | Standard Deviation 0.6 |
| Endotracheal Tube | Cardiac Index (CI) | 20 minutes post-induction | 2.8 L/min/m^2 | Standard Deviation 0.5 |
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.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Duration of Surgery | 61 minutes | Standard Deviation 29 |
| Endotracheal Tube | Duration of Surgery | 57 minutes | Standard Deviation 44 |
p-value: 0.8322t-test, 2 sided
Primary
Heart Rate
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Population: Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Heart Rate | Induction | 65 beats per minute | Standard Deviation 11 |
| THRIVE | Heart Rate | 10 minutes post-induction | 72 beats per minute | Standard Deviation 12 |
| THRIVE | Heart Rate | 20 minutes post-induction | 79 beats per minute | Standard Deviation 13 |
| THRIVE | Heart Rate | 30 minutes post-induction | 79 beats per minute | Standard Deviation 14 |
| THRIVE | Heart Rate | 40 minutes post-induction | 81 beats per minute | Standard Deviation 15 |
| THRIVE | Heart Rate | Spontaneous ventilation | 72 beats per minute | Standard Deviation 14 |
| Endotracheal Tube | Heart Rate | 40 minutes post-induction | 73 beats per minute | Standard Deviation 9 |
| Endotracheal Tube | Heart Rate | Induction | 70 beats per minute | Standard Deviation 15 |
| Endotracheal Tube | Heart Rate | 30 minutes post-induction | 76 beats per minute | Standard Deviation 12 |
| Endotracheal Tube | Heart Rate | 10 minutes post-induction | 81 beats per minute | Standard Deviation 14 |
| Endotracheal Tube | Heart Rate | Spontaneous ventilation | 71 beats per minute | Standard Deviation 15 |
| Endotracheal Tube | Heart Rate | 20 minutes post-induction | 79 beats per minute | Standard Deviation 9 |
Primary
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | 97 percentage of oxygen | Standard Deviation 2 |
| Endotracheal Tube | Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | 97 percentage of oxygen | Standard Deviation 3 |
p-value: 0.7934t-test, 2 sided
Primary
Mean Arterial Pressure (MAP)
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Population: Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Mean Arterial Pressure (MAP) | 10 minutes post-induction | 78 mmHg | Standard Deviation 12 |
| THRIVE | Mean Arterial Pressure (MAP) | 30 minutes post-induction | 72 mmHg | Standard Deviation 12 |
| THRIVE | Mean Arterial Pressure (MAP) | Induction | 90 mmHg | Standard Deviation 16 |
| THRIVE | Mean Arterial Pressure (MAP) | 40 minutes post-induction | 69 mmHg | Standard Deviation 13 |
| THRIVE | Mean Arterial Pressure (MAP) | Spontaneous ventilation | 88 mmHg | Standard Deviation 14 |
| THRIVE | Mean Arterial Pressure (MAP) | 20 minutes post-induction | 71 mmHg | Standard Deviation 9 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | Spontaneous ventilation | 88 mmHg | Standard Deviation 18 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | Induction | 92 mmHg | Standard Deviation 12 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | 10 minutes post-induction | 76 mmHg | Standard Deviation 9 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | 20 minutes post-induction | 83 mmHg | Standard Deviation 17 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | 30 minutes post-induction | 85 mmHg | Standard Deviation 13 |
| Endotracheal Tube | Mean Arterial Pressure (MAP) | 40 minutes post-induction | 80 mmHg | Standard Deviation 12 |
Primary
Number of Suspension Adjustments
Number of adjustments of the suspension laryngoscope.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Number of Suspension Adjustments | 1 adjustments | Standard Deviation 1 |
| Endotracheal Tube | Number of Suspension Adjustments | 2 adjustments | Standard Deviation 4 |
p-value: 0.6479t-test, 2 sided
Primary
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)
Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | Induction | 32 mmHg | Standard Deviation 5 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | 10 minutes post-induction | 54 mmHg | Standard Deviation 5 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | 20 minutes post-induction | 65 mmHg | Standard Deviation 9 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | 30 minutes post-induction | 77 mmHg | Standard Deviation 8 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | 40 minutes post-induction | 86 mmHg | Standard Deviation 7 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | Spontaneous ventilation | 71 mmHg | Standard Deviation 13 |
| THRIVE | Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2) | Recovery room | 37 mmHg | Standard Deviation 5 |
Primary
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)
Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | Induction | 365 mmHg | Standard Deviation 40 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | 10 minutes post-induction | 294 mmHg | Standard Deviation 79 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | 20 minutes post-induction | 279 mmHg | Standard Deviation 81 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | 30 minutes post-induction | 245 mmHg | Standard Deviation 81 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | 40 minutes post-induction | 223 mmHg | Standard Deviation 67 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | Spontaneous ventilation | 251 mmHg | Standard Deviation 102 |
| THRIVE | Partial Pressure of Oxygen in the Arterial Blood (PaO2) | Recovery room | 86 mmHg | Standard Deviation 13 |
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.
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)
Population: This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | pH in Blood | Induction | 7.4 pH | Standard Deviation 0 |
| THRIVE | pH in Blood | 10 minutes post-induction | 7.2 pH | Standard Deviation 0 |
| THRIVE | pH in Blood | 20 minutes post-induction | 7.2 pH | Standard Deviation 0 |
| THRIVE | pH in Blood | 30 minutes post-induction | 7.1 pH | Standard Deviation 0 |
| THRIVE | pH in Blood | 40 minutes post-induction | 7.1 pH | Standard Deviation 0.1 |
| THRIVE | pH in Blood | Spontaneous ventilation | 7.4 pH | Standard Deviation 0.1 |
| THRIVE | pH in Blood | Recovery room | 7.4 pH | Standard Deviation 0 |
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).
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Population: Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Stroke Volume Index (SVI) | Induction | 50 ml/b/m^2 | Standard Deviation 10 |
| THRIVE | Stroke Volume Index (SVI) | 10 minutes post-induction | 45 ml/b/m^2 | Standard Deviation 7 |
| THRIVE | Stroke Volume Index (SVI) | 20 minutes post-induction | 48 ml/b/m^2 | Standard Deviation 10 |
| THRIVE | Stroke Volume Index (SVI) | 30 minutes post-induction | 51 ml/b/m^2 | Standard Deviation 12 |
| THRIVE | Stroke Volume Index (SVI) | 40 minutes post-induction | 52 ml/b/m^2 | Standard Deviation 6 |
| THRIVE | Stroke Volume Index (SVI) | Spontaneous ventilation | 54 ml/b/m^2 | Standard Deviation 17 |
| Endotracheal Tube | Stroke Volume Index (SVI) | 40 minutes post-induction | 43 ml/b/m^2 | Standard Deviation 10 |
| Endotracheal Tube | Stroke Volume Index (SVI) | Induction | 48 ml/b/m^2 | Standard Deviation 13 |
| Endotracheal Tube | Stroke Volume Index (SVI) | 30 minutes post-induction | 39 ml/b/m^2 | Standard Deviation 9 |
| Endotracheal Tube | Stroke Volume Index (SVI) | 10 minutes post-induction | 36 ml/b/m^2 | Standard Deviation 7 |
| Endotracheal Tube | Stroke Volume Index (SVI) | Spontaneous ventilation | 53 ml/b/m^2 | Standard Deviation 12 |
| Endotracheal Tube | Stroke Volume Index (SVI) | 20 minutes post-induction | 35 ml/b/m^2 | Standard Deviation 6 |
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).
Time frame: Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)
Population: Participants with measurements at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Systemic Vascular Resistance Index (SVRI) | 10 minutes post-induction | 1769 dynes*s/cm^5/m^2 | Standard Deviation 549 |
| THRIVE | Systemic Vascular Resistance Index (SVRI) | Induction | 2249 dynes*s/cm^5/m^2 | Standard Deviation 652 |
| THRIVE | Systemic Vascular Resistance Index (SVRI) | 40 minutes post-induction | 1130 dynes*s/cm^5/m^2 | Standard Deviation 217 |
| THRIVE | Systemic Vascular Resistance Index (SVRI) | 20 minutes post-induction | 1341 dynes*s/cm^5/m^2 | Standard Deviation 321 |
| THRIVE | Systemic Vascular Resistance Index (SVRI) | Spontaneous ventilation | 1841 dynes*s/cm^5/m^2 | Standard Deviation 443 |
| THRIVE | Systemic Vascular Resistance Index (SVRI) | 30 minutes post-induction | 1330 dynes*s/cm^5/m^2 | Standard Deviation 464 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | Spontaneous ventilation | 2152 dynes*s/cm^5/m^2 | Standard Deviation 578 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | Induction | 2140 dynes*s/cm^5/m^2 | Standard Deviation 443 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | 10 minutes post-induction | 2026 dynes*s/cm^5/m^2 | Standard Deviation 446 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | 20 minutes post-induction | 2182 dynes*s/cm^5/m^2 | Standard Deviation 440 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | 30 minutes post-induction | 2080 dynes*s/cm^5/m^2 | Standard Deviation 446 |
| Endotracheal Tube | Systemic Vascular Resistance Index (SVRI) | 40 minutes post-induction | 1187 dynes*s/cm^5/m^2 | Standard Deviation 530 |
Primary
Time to Suspension
Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Suspension | 4 minutes | Standard Deviation 2 |
| Endotracheal Tube | Time to Suspension | 3 minutes | Standard Deviation 2 |
p-value: 0.7549t-test, 2 sided
Secondary
Analgesic Consumption
Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Time frame: Recovery room to 7th postoperative day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Analgesic Consumption | 12 MME | Standard Deviation 17 |
| Endotracheal Tube | Analgesic Consumption | 8 MME | Standard Deviation 7 |
p-value: 0.4324t-test, 2 sided
Secondary
Apnea Time
Recorded from induction of anesthesia to the return of spontaneous ventilation.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Apnea Time | 70 minutes | Standard Deviation 28 |
| Endotracheal Tube | Apnea Time | 87 minutes | Standard Deviation 48 |
p-value: 0.3346t-test, 2 sided
Secondary
Count of Participants Requiring Jet Ventilation
Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THRIVE | Count of Participants Requiring Jet Ventilation | 7 Participants |
| Endotracheal Tube | Count of Participants Requiring Jet Ventilation | 0 Participants |
Secondary
Duration of Anesthesia
Recorded from induction of anesthesia to patient's awakening/extubation
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Duration of Anesthesia | 78 minutes | Standard Deviation 28 |
| Endotracheal Tube | Duration of Anesthesia | 89 minutes | Standard Deviation 48 |
p-value: 0.5513t-test, 2 sided
Secondary
First Pain Score in Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time frame: Duration of recovery room stay (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | First Pain Score in Recovery Room | 2 score on a scale | Standard Deviation 4 |
| Endotracheal Tube | First Pain Score in Recovery Room | 3 score on a scale | Standard Deviation 3 |
p-value: 0.6587t-test, 2 sided
Secondary
Pain Score at Discharge From Recovery Room
Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).
Time frame: Duration of recovery room stay (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Pain Score at Discharge From Recovery Room | 3 score on a scale | Standard Deviation 2 |
| Endotracheal Tube | Pain Score at Discharge From Recovery Room | 2 score on a scale | Standard Deviation 2 |
p-value: 0.4143t-test, 2 sided
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.
Time frame: Prior to procedure, and 1-2 hours after procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Quality of Recovery (QoR)15 Score | Preoperative | 135 score on a scale | Standard Deviation 17 |
| THRIVE | Quality of Recovery (QoR)15 Score | Postoperative | 146 score on a scale | Standard Deviation 5 |
| Endotracheal Tube | Quality of Recovery (QoR)15 Score | Preoperative | 138 score on a scale | Standard Deviation 8 |
| Endotracheal Tube | Quality of Recovery (QoR)15 Score | Postoperative | 136 score on a scale | Standard Deviation 11 |
Comparison: Comparison of preoperative scores.p-value: 0.7221t-test, 2 sided
Comparison: Comparison of postoperative scores.p-value: 0.0336t-test, 2 sided
Secondary
Recovery Room Discharge-ready Time
From admission to recovery room, to discharge from recovery room
Time frame: Duration of recovery room stay (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Recovery Room Discharge-ready Time | 64 minutes | Standard Deviation 18 |
| Endotracheal Tube | Recovery Room Discharge-ready Time | 62 minutes | Standard Deviation 12 |
p-value: 0.8112t-test, 2 sided
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.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Patient Being Alert and Oriented x 4 | 23 minutes | Standard Deviation 29 |
| Endotracheal Tube | Time to Patient Being Alert and Oriented x 4 | 23 minutes | Standard Deviation 19 |
p-value: 0.9856t-test, 2 sided
Secondary
Time to Spontaneous Ventilation
Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Spontaneous Ventilation | 5 minutes | Standard Deviation 4 |
| Endotracheal Tube | Time to Spontaneous Ventilation | 11 minutes | Standard Deviation 5 |
p-value: 0.0058t-test, 2 sided
Secondary
Total Ephedrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Population: Participants who received ephedrine are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Total Ephedrine Dose (Vasoactive Drug) | 4 mg | Standard Deviation 8 |
| Endotracheal Tube | Total Ephedrine Dose (Vasoactive Drug) | 1 mg | Standard Deviation 2 |
p-value: 0.2827t-test, 2 sided
Secondary
Total Labetalol Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Population: Participants who received labetalol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Total Labetalol Dose (Vasoactive Drug) | 15 mg | Standard Deviation 22 |
| Endotracheal Tube | Total Labetalol Dose (Vasoactive Drug) | 13 mg | Standard Deviation 21 |
p-value: 0.8426t-test, 2 sided
Secondary
Total Phenylephrine Dose (Vasoactive Drug)
Time frame: Duration of surgery (average approximately 1 hour)
Population: Participants who received phenylephrine are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Total Phenylephrine Dose (Vasoactive Drug) | 300 mg | Standard Deviation 591 |
| Endotracheal Tube | Total Phenylephrine Dose (Vasoactive Drug) | 479 mg | Standard Deviation 757 |
p-value: 0.5625t-test, 2 sided
Secondary
Total Propofol Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Total Propofol Dose (Anesthetic) | 730 mg | Standard Deviation 288 |
| Endotracheal Tube | Total Propofol Dose (Anesthetic) | 920 mg | Standard Deviation 388 |
p-value: 0.1927t-test, 2 sided
Secondary
Total Remifentanil Dose (Anesthetic)
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Total Remifentanil Dose (Anesthetic) | 996 µg | Standard Deviation 674 |
| Endotracheal Tube | Total Remifentanil Dose (Anesthetic) | 1114 µg | Standard Deviation 432 |
p-value: 0.6483t-test, 2 sided