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

NCT03086408 | Completed Results FDA Device

• 1 other identifier: 40295
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchoscopy

Keywords

airway management; high flow nasal oxygen; high flow nasal cannula; THRIVE

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Time to Patient Being Alert and Oriented x 4

  Duration of surgery (average approximately 1 hour)

• Recovery Room Discharge-ready Time

  Duration of recovery room stay (average approximately 1 hour)

• First Pain Score in Recovery Room

  Duration of recovery room stay (average approximately 1 hour)

• Discharge-ready Pain Score

  Day of discharge (up to 2 minutes)

• Analgesic Consumption

  Recovery room to 7th postoperative day

Study Arms (2)

THRIVE

EXPERIMENTAL

high flow nasal oxygen

Device: THRIVE

endotracheal tube or supraglottic airway

ACTIVE COMPARATOR

tracheal intubation or supraglottic airway device

Device: Endotracheal tube or Supraglottic airway

Interventions

THRIVE DEVICE

active nasal oxygen delivery system

THRIVE

Endotracheal tube or Supraglottic airway DEVICE

Plastic devices for mechanical ventilation

endotracheal tube or supraglottic airway

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for diagnostic bronchoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Vladimir Nekhendzy, M.D., FASA
• Organization: Stanford University

nek@stanford.edu

650-498-4055

Study Officials

• Vladimir Nekhendzy, MD

  Stanford University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology and Otolaryngology

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 22, 2017
• Study Start: May 9, 2017
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: July 17, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)