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

NCT ID: NCT03086408

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2019-06-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THRIVE

high flow nasal oxygen

Group Type: EXPERIMENTAL

THRIVE

Intervention Type: DEVICE

active nasal oxygen delivery system

endotracheal tube or supraglottic airway

tracheal intubation or supraglottic airway device

Group Type: ACTIVE_COMPARATOR

Endotracheal tube or Supraglottic airway

Intervention Type: DEVICE

Plastic devices for mechanical ventilation

Interventions

THRIVE

active nasal oxygen delivery system

Intervention Type: DEVICE

Endotracheal tube or Supraglottic airway

Plastic devices for mechanical ventilation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Nekhendzy

Clinical Professor of Anesthesiology and Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Nekhendzy, MD

Role: STUDY_CHAIR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

40295

Identifier Type: -

Identifier Source: org_study_id