Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy

Stanford University

Status: Completed

Conditions: Bronchoscopy

Treatments: Device: THRIVE; Device: Endotracheal tube or Supraglottic airway

Study type: Interventional

Funder types: Other

Identifiers

NCT03086408

40295

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

THRIVE

Experimental group

Description:

high flow nasal oxygen

Treatment:

Device: THRIVE

endotracheal tube or supraglottic airway

Active Comparator group

Description:

tracheal intubation or supraglottic airway device

Treatment:

Device: Endotracheal tube or Supraglottic airway