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

Not Applicable

Completed

Conditions: Bronchoscopy

Interventions: Device: Endotracheal tube or Supraglottic airway
Device: THRIVE

Registration Number: NCT03086408

Lead Sponsor: Stanford University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endotracheal tube or supraglottic airway	Endotracheal tube or Supraglottic airway	tracheal intubation or supraglottic airway device
THRIVE	THRIVE	high flow nasal oxygen

Primary Outcome Measures

Name	Time	Method
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.
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)
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.
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.

Secondary Outcome Measures

Name	Time	Method
Recovery Room Discharge-ready Time	Duration of recovery room stay (average approximately 1 hour)	From admission to recovery room, to discharge from recovery room
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.
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)