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

The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures

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.

Study Overview

• Status: Completed
• Conditions: Bronchoscopy
• Intervention / Treatment: Device: THRIVE; Device: Endotracheal tube or Supraglottic airway

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THRIVE; high flow nasal oxygen	Device: THRIVE; active nasal oxygen delivery system
Active Comparator: endotracheal tube or supraglottic airway; tracheal intubation or supraglottic airway device	Device: Endotracheal tube or Supraglottic airway; Plastic devices for mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)	Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.	Duration of surgery (average approximately 1 hour)
Awakening/Extubation Time	Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.	Duration of surgery (average approximately 1 hour)
Time to Bronchoscope Placement in Trachea	Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.	Duration of surgery (average approximately 1 hour)
Number of Tracheal Bronchoscope Placements Required		Duration of surgery (average approximately 1 hour)
Duration of Procedure	Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.	Duration of surgery (average approximately 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time	From admission to recovery room, to discharge from recovery room	Duration of recovery room stay (average approximately 1 hour)
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).	Duration of recovery room stay (average approximately 1 hour)
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).	Day of discharge (up to 2 minutes)
Analgesic Consumption	Analgesic consumption was measured in oral morphine milligram equivalents (MME)	Recovery room to 7th postoperative day

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Chair: Vladimir Nekhendzy, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Actual): June 10, 2019
• Study Completion (Actual): June 10, 2019

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: airway management; high flow nasal cannula; high flow nasal oxygen; THRIVE
• Other Study ID Numbers: 40295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No