Ventilatory Effects of THRIVE During EBUS

Hypercapnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505279
• Other study ID #: 2022-2031
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2022
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Rijnstate Hospital
• Contact: Jeffrey Miechels
• Phone: 0031-88-0058888
• Email: jmiechels[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High Flow Nasal Cannula
• Hypercapnia
• Sedation Complication

Intervention

Device:
• THRIVE (High Flow Nasal Cannula)
2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory CO2 at 10 minutes (baseline)	Inspiratory CO2, measured at the carinal level	at t=10 minutes
Primary	Inspiratory CO2 at 25 minutes	Inspiratory CO2, measured at the carinal level	at=25 minutes
Primary	Inspiratory CO2 at 45 minutes	Inspiratory CO2, measured at the carinal level	at t=45 minutes
Primary	expiratory CO2 at 10 minutes (baseline)	Expiratory CO2, measured at the carinal level	at t=10 minutes
Primary	expiratory CO2 at 25 minutes	Expiratory CO2, measured at the carinal level	at t=25 minutes
Primary	expiratory CO2 at 45 minutes	Expiratory CO2, measured at the carinal level	t=45 minutes
Primary	Slope of capnography at 10 minutes (baseline)	Angle of the D-E segment (inspiratory slope)	At t=10 minutes
Primary	Slope of capnography at 25 minutes	Angle of the D-E segment (inspiratory slope)	At t=25 minutes
Primary	Slope of capnography at 45 minutes	Angle of the D-E segment (inspiratory slope)	At t=45 minutes
Secondary	Respiratory rate	Respiratory rate, measured by capnography	At t=10 minutes
Secondary	Respiratory rate	Respiratory rate, measured by capnography	At t=25 minutes
Secondary	Respiratory rate	Respiratory rate, measured by capnography	At t=45 minutes
Secondary	The level of HFNC dead space washout	Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.	At t=10 minutes
Secondary	The level of HFNC dead space washout	Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.	At t=25 minutes
Secondary	The level of HFNC dead space washout	Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.	At t=45 minutes