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

Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086408
• Other study ID #: 40295
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: June 10, 2019

Study information

• Verified date: July 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Device:
• THRIVE
active nasal oxygen delivery system
• Endotracheal tube or Supraglottic airway
Plastic devices for mechanical ventilation

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Number of Tracheal Bronchoscope Placements Required		Duration of surgery (average approximately 1 hour)
Primary	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	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)
Secondary	Recovery Room Discharge-ready Time	From admission to recovery room, to discharge from recovery room	Duration of recovery room stay (average approximately 1 hour)
Secondary	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)
Secondary	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)
Secondary	Analgesic Consumption	Analgesic consumption was measured in oral morphine milligram equivalents (MME)	Recovery room to 7th postoperative day