Clinical trial NCT03086408: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy
Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Keywords: airway management
high flow nasal oxygen
high flow nasal cannula
THRIVE
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Awakening/Extubation Time
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Time to Bronchoscope Placement in Trachea
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Number of Tracheal Bronchoscope Placements Required
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Duration of Procedure
timeFrame: Duration of surgery (average approximately 1 hour)
Secondary outcomes:
measure: Time to Patient Being Alert and Oriented x 4
timeFrame: Duration of surgery (average approximately 1 hour)
measure: Recovery Room Discharge-ready Time
timeFrame: Duration of recovery room stay (average approximately 1 hour)
measure: First Pain Score in Recovery Room
timeFrame: Duration of recovery room stay (average approximately 1 hour)
measure: Discharge-ready Pain Score
timeFrame: Day of discharge (up to 2 minutes)
measure: Analgesic Consumption
timeFrame: Recovery room to 7th postoperative day
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Vladimir Nekhendzy, MD
role: STUDY_CHAIR
References: