Bronchoscopy
Conditions
Keywords
airway management, high flow nasal oxygen, high flow nasal cannula, THRIVE
Brief summary
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.
Interventions
DEVICETHRIVE
active nasal oxygen delivery system
DEVICEEndotracheal tube or Supraglottic airway
Plastic devices 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 diagnostic bronchoscopy
Exclusion criteria
* Patients with significantly decreased myocardial function (ejection fraction \< 50%) * Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions. * Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication. * Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs). * Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2. * Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range. * Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes). * Patients with skull base defects. * Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range. * 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%. * Obese patients with BMI above 35 kg/m2. * Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment. * Patients with hiatal hernia and full stomach patients. * Patients on immunosuppressive medications. * Patient's refusal to participate in the study. * Patients who do not understand English or mentally handicapped. * Pregnant or breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Procedure | Duration of surgery (average approximately 1 hour) | Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure. |
| 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. |
| 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 Bronchoscope Placement in Trachea | Duration of surgery (average approximately 1 hour) | Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement. |
| Number of Tracheal Bronchoscope Placements Required | Duration of surgery (average approximately 1 hour) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Patient Being Alert and Oriented x 4 | Duration of surgery (average approximately 1 hour) | 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. |
| 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 was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). |
| Discharge-ready Pain Score | Day of discharge (up to 2 minutes) | Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable). |
| Analgesic Consumption | Recovery room to 7th postoperative day | Analgesic consumption was measured in oral morphine milligram equivalents (MME) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THRIVE Participants receive THRIVE active nasal oxygen delivery system. | 10 |
| Endotracheal Tube or Supraglottic Airway Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Endotracheal Tube or Supraglottic Airway | Total | THRIVE |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 16.17 | 55.0 years STANDARD_DEVIATION 17.24 | 53.5 years STANDARD_DEVIATION 19.01 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 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 | 10.1 minutes | Standard Deviation 2.42 |
| Endotracheal Tube or Supraglottic Airway | Awakening/Extubation Time | 9.2 minutes | Standard Deviation 4.87 |
p-value: 0.6195% CI: [-2.89, 4.69]t-test, 2 sided
Primary
Duration of Procedure
Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Duration of Procedure | 15.6 minutes | Standard Deviation 7.9 |
| Endotracheal Tube or Supraglottic Airway | Duration of Procedure | 15.5 minutes | Standard Deviation 11.17 |
p-value: 0.9895% CI: [-8.62, 8.82]t-test, 2 sided
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) | 94.7 percentage of oxygen | Standard Deviation 6.65 |
| Endotracheal Tube or Supraglottic Airway | Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) | 98.7 percentage of oxygen | Standard Deviation 1.7 |
p-value: 0.0995% CI: [-9, 1]t-test, 2 sided
Primary
Number of Tracheal Bronchoscope Placements Required
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Number of Tracheal Bronchoscope Placements Required | 0.2 placements | Standard Deviation 0.42 |
| Endotracheal Tube or Supraglottic Airway | Number of Tracheal Bronchoscope Placements Required | 0.6 placements | Standard Deviation 1.07 |
p-value: 0.395% CI: [-1.3, 0.5]t-test, 2 sided
Primary
Time to Bronchoscope Placement in Trachea
Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Bronchoscope Placement in Trachea | 1.03 minutes | Standard Deviation 0.38 |
| Endotracheal Tube or Supraglottic Airway | Time to Bronchoscope Placement in Trachea | 1.1 minutes | Standard Deviation 0.68 |
p-value: 0.7895% CI: [-0.61, 0.47]t-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 | 0.5 MME | Standard Deviation 1.58 |
| Endotracheal Tube or Supraglottic Airway | Analgesic Consumption | 2 MME | Standard Deviation 4.83 |
p-value: 0.3795% CI: [-5.29, 2.29]t-test, 2 sided
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).
Time frame: Day of discharge (up to 2 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Discharge-ready Pain Score | 1.1 score on a scale | Standard Deviation 1.66 |
| Endotracheal Tube or Supraglottic Airway | Discharge-ready Pain Score | 1.3 score on a scale | Standard Deviation 2.26 |
p-value: 0.8295% CI: [-2.38, 1.98]t-test, 2 sided
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).
Time frame: Duration of recovery room stay (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | First Pain Score in Recovery Room | 1.3 score on a scale | Standard Deviation 2.41 |
| Endotracheal Tube or Supraglottic Airway | First Pain Score in Recovery Room | 1.3 score on a scale | Standard Deviation 2.41 |
p-value: 195% CI: [-2.8, 2.8]t-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 | 30.3 minutes | Standard Deviation 17.09 |
| Endotracheal Tube or Supraglottic Airway | Recovery Room Discharge-ready Time | 16.6 minutes | Standard Deviation 8.38 |
p-value: 0.0495% CI: [0.63, 26.77]t-test, 2 sided
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.
Time frame: Duration of surgery (average approximately 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THRIVE | Time to Patient Being Alert and Oriented x 4 | 1.2 minutes | Standard Deviation 3.12 |
| Endotracheal Tube or Supraglottic Airway | Time to Patient Being Alert and Oriented x 4 | 0.67 minutes | Standard Deviation 0.87 |
p-value: 0.6195% CI: [-1.64, 2.84]t-test, 2 sided