Laryngologic Surgical Procedures
Conditions
Keywords
airway management, high flow nasal oxygen, high flow nasal cannula, THRIVE
Brief 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. 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).
Interventions
DEVICETHRIVE
active nasal oxygen delivery system
DEVICEEndotracheal tube
a plastic tube for mechanical ventilation
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 short, non-laser laryngologic 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 SpO2 \< 95%. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) | intraoperative (up to one hour) | — |
| Time to Awakening From Anesthesia (Primary Anesthesia Outcome) | intraoperative (up to 20 min) | time from end of surgery to responding to commands/extubation |
| Suspension Time (Primary Surgical Outcome) | 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) | 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) | intraoperative (up to one hour) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alertness | Recovery room admission (up to 30 min following admission to recovery room) | Time required for the patient to become fully alert and oriented per standard recovery room evaluation |
| Quality of Recovery | One week after surgery | 15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome. |
| Recovery Room Time | Up to 2 hours after procedure | — |
| Numerical Pain Rating Scores | Recovery room admission and discharge (up to 2 hours) | A score from 0 to 10, higher scores corresponding to higher pain |
| Opioid Consumption | Recovery room admission and discharge (up to 2 hours) | Total oral opioid consumption in morphine milligram equivalents |
| Change in Voice Handicap Index (VHI) | Preoperative assessment and one month after surgery | numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THRIVE THRIVE: active nasal oxygen delivery system | 10 |
| Control Group Endotracheal tube or Supraglottic jet ventilation | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | THRIVE | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 12.42 | 55.2 years STANDARD_DEVIATION 17.29 | 53.1 years STANDARD_DEVIATION 14.82 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 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
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
Time frame: intraoperative (up to one hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) | 93 percentage of saturation (SpO2) | Standard Deviation 5.66 |
| Control Group | Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome) | 98.7 percentage of saturation (SpO2) | Standard Deviation 1.57 |
p-value: 0.006t-test, 2 sided
Primary
Duration of Surgery (Primary Surgical Outcome)
Time frame: intraoperative (up to one hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Duration of Surgery (Primary Surgical Outcome) | 19.1 minutes | Standard Deviation 10.82 |
| Control Group | Duration of Surgery (Primary Surgical Outcome) | 20.9 minutes | Standard Deviation 8.85 |
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
Time frame: intraoperative (up to 5 min)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome) | 0.4 maneuvers | Standard Deviation 0.52 |
| Control Group | Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome) | 1.7 maneuvers | Standard Deviation 0.95 |
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
Time frame: intraoperative (up to 5 min)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Suspension Time (Primary Surgical Outcome) | 1.8 minutes | Standard Deviation 1.1 |
| Control Group | Suspension Time (Primary Surgical Outcome) | 4.3 minutes | Standard Deviation 2.1 |
Primary
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
time from end of surgery to responding to commands/extubation
Time frame: intraoperative (up to 20 min)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Awakening From Anesthesia (Primary Anesthesia Outcome) | 10.3 minutes | Standard Deviation 4 |
| Control Group | Time to Awakening From Anesthesia (Primary Anesthesia Outcome) | 9.4 minutes | Standard Deviation 3.4 |
Secondary
Alertness
Time required for the patient to become fully alert and oriented per standard recovery room evaluation
Time frame: Recovery room admission (up to 30 min following admission to recovery room)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Alertness | 4.3 minutes | Standard Deviation 6.3 |
| Control Group | Alertness | 4.8 minutes | Standard Deviation 7.4 |
Secondary
Change in Voice Handicap Index (VHI)
numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome
Time frame: Preoperative assessment and one month after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Change in Voice Handicap Index (VHI) | one month after surgery | 7.6 score on a scale | Standard Deviation 12.19 |
| THRIVE | Change in Voice Handicap Index (VHI) | preoperative | 12.8 score on a scale | Standard Deviation 12.63 |
| Control Group | Change in Voice Handicap Index (VHI) | preoperative | 22.7 score on a scale | Standard Deviation 12.06 |
| Control Group | Change in Voice Handicap Index (VHI) | one month after surgery | 13.6 score on a scale | Standard Deviation 13.22 |
Secondary
Numerical Pain Rating Scores
A score from 0 to 10, higher scores corresponding to higher pain
Time frame: Recovery room admission and discharge (up to 2 hours)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THRIVE | Numerical Pain Rating Scores | recovery room admission | 1.3 score on a scale | Standard Deviation 1.95 |
| THRIVE | Numerical Pain Rating Scores | recovery room discharge | 0.9 score on a scale | Standard Deviation 1.29 |
| Control Group | Numerical Pain Rating Scores | recovery room admission | 3.7 score on a scale | Standard Deviation 2.91 |
| Control Group | Numerical Pain Rating Scores | recovery room discharge | 2.7 score on a scale | Standard Deviation 1.77 |
Secondary
Opioid Consumption
Total oral opioid consumption in morphine milligram equivalents
Time frame: Recovery room admission and discharge (up to 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Opioid Consumption | 8.8 MME: morphine milligram equivalents | Standard Deviation 11 |
| Control Group | Opioid Consumption | 22.5 MME: morphine milligram equivalents | Standard Deviation 22.1 |
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.
Time frame: One week after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Quality of Recovery | 142.5 score on a scale | Standard Deviation 15.7 |
| Control Group | Quality of Recovery | 131.2 score on a scale | Standard Deviation 17.9 |
Secondary
Recovery Room Time
Time frame: Up to 2 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Recovery Room Time | 65.7 minutes | Standard Deviation 43.41 |
| Control Group | Recovery Room Time | 77.7 minutes | Standard Deviation 42.84 |