N/A N=20 Randomized Double-blind Treatment

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

Bronchoscopy

Bottom Line

View on ClinicalTrials.gov: NCT03086408 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) — 94.7; 98.7 percentage of oxygen — p=0.09

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: THRIVE (Device); Endotracheal tube or Supraglottic airway (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)	94.7; 98.7	0.09
PRIMARY Awakening/Extubation Time	10.1; 9.2	0.61
PRIMARY Time to Bronchoscope Placement in Trachea	1.03; 1.1	0.78
PRIMARY Number of Tracheal Bronchoscope Placements Required	0.2; 0.6	0.30
PRIMARY Duration of Procedure	15.6; 15.5	0.98
SECONDARY Time to Patient Being Alert and Oriented x 4	1.2; 0.67	0.61
SECONDARY Recovery Room Discharge-ready Time	30.3; 16.6	0.04 sig
SECONDARY First Pain Score in Recovery Room	1.3; 1.3	1
SECONDARY Discharge-ready Pain Score	1.1; 1.3	0.82
SECONDARY Analgesic Consumption	0.5; 2	0.37

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03086408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.