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Completed

NCT Number: NCT03086408

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THRIVE

Device

active nasal oxygen delivery system

Endotracheal tube or Supraglottic airway

Device

Plastic devices for mechanical ventilation

Primary outcomes

  1. Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)

    Time frame: Duration of surgery (average approximately 1 hour)

    Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.

  2. Awakening/Extubation Time

    Time frame: Duration of surgery (average approximately 1 hour)

    Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.

  3. Time to Bronchoscope Placement in Trachea

    Time frame: Duration of surgery (average approximately 1 hour)

    Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.

  4. Number of Tracheal Bronchoscope Placements Required

    Time frame: Duration of surgery (average approximately 1 hour)

  5. Duration of Procedure

    Time frame: Duration of surgery (average approximately 1 hour)

    Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.

Secondary outcomes

  1. Time to Patient Being Alert and Oriented x 4

    Time frame: Duration of surgery (average approximately 1 hour)

    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.

  2. Recovery Room Discharge-ready Time

    Time frame: Duration of recovery room stay (average approximately 1 hour)

    From admission to recovery room, to discharge from recovery room

  3. First Pain Score in Recovery Room

    Time frame: Duration of recovery room stay (average approximately 1 hour)

    Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).

  4. Discharge-ready Pain Score

    Time frame: Day of discharge (up to 2 minutes)

    Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).

  5. Analgesic Consumption

    Time frame: Recovery room to 7th postoperative day

    Analgesic consumption was measured in oral morphine milligram equivalents (MME)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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