Skip to main content
OpenTrials
Completed

NCT Number: NCT05505279

Ventilatory Effects of THRIVE During EBUS

High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.

This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.

A randomized, double-blinded, cross-over study is designed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercapnia High Flow Nasal Cannula Pathological Conditions, Signs and Symptoms Sedation Complication Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with COPD Gold classification 3 or 4
  • Scheduled EBUS with sedation

Exclusion criteria

  • Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré.
  • Allergy or intolerance for propofol or esketamine
  • Severe pulmonary hypertension (PAPsyst > 60 mmHg)
  • Pregnancy
  • upper airway obstruction, such as subglottic stenosis or obstructing tumors.

Treatment and study plan

THRIVE (High Flow Nasal Cannula)

Device

2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen

Other names: THRIVE, Optiflow, High Flow Nasal Cannula, High Flow Nasal Oxygen

Primary outcomes

  1. Inspiratory CO2 at 10 minutes (baseline)

    Time frame: at t=10 minutes

    Inspiratory CO2, measured at the carinal level

  2. Inspiratory CO2 at 25 minutes

    Time frame: at=25 minutes

    Inspiratory CO2, measured at the carinal level

  3. Inspiratory CO2 at 45 minutes

    Time frame: at t=45 minutes

    Inspiratory CO2, measured at the carinal level

  4. expiratory CO2 at 10 minutes (baseline)

    Time frame: at t=10 minutes

    Expiratory CO2, measured at the carinal level

  5. expiratory CO2 at 25 minutes

    Time frame: at t=25 minutes

    Expiratory CO2, measured at the carinal level

  6. expiratory CO2 at 45 minutes

    Time frame: t=45 minutes

    Expiratory CO2, measured at the carinal level

  7. Slope of capnography at 10 minutes (baseline)

    Time frame: At t=10 minutes

    Angle of the D-E segment (inspiratory slope)

  8. Slope of capnography at 25 minutes

    Time frame: At t=25 minutes

    Angle of the D-E segment (inspiratory slope)

  9. Slope of capnography at 45 minutes

    Time frame: At t=45 minutes

    Angle of the D-E segment (inspiratory slope)

Secondary outcomes

  1. Respiratory rate

    Time frame: At t=10 minutes

    Respiratory rate, measured by capnography

  2. Respiratory rate

    Time frame: At t=25 minutes

    Respiratory rate, measured by capnography

  3. Respiratory rate

    Time frame: At t=45 minutes

    Respiratory rate, measured by capnography

  4. The level of HFNC dead space washout

    Time frame: At t=10 minutes

    Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

  5. The level of HFNC dead space washout

    Time frame: At t=25 minutes

    Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

  6. The level of HFNC dead space washout

    Time frame: At t=45 minutes

    Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Aug 15, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.