Ventilatory Effects of THRIVE During EBUS

Phase 3

Completed

• Conditions: High Flow Nasal Cannula; Hypercapnia; Sedation Complication
• Interventions: Device: THRIVE (High Flow Nasal Cannula)

• Registration Number: NCT05505279
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-10-05
• Status Verified: 2024-08
• Primary Completion: 2024-08-08
• Study Completion: 2024-08-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
30 L - 70 L	THRIVE (High Flow Nasal Cannula)	Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 30L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 70 L/min for another 15 minutes.
70 L - 30 L	THRIVE (High Flow Nasal Cannula)	Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 70L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 30 L/min for another 15 minutes.

Primary Outcome Measures

Name	Time	Method
Inspiratory CO2 at 45 minutes	at t=45 minutes	Inspiratory CO2, measured at the carinal level
expiratory CO2 at 25 minutes	at t=25 minutes	Expiratory CO2, measured at the carinal level
expiratory CO2 at 45 minutes	t=45 minutes	Expiratory CO2, measured at the carinal level
Slope of capnography at 45 minutes	At t=45 minutes	Angle of the D-E segment (inspiratory slope)
Inspiratory CO2 at 10 minutes (baseline)	at t=10 minutes	Inspiratory CO2, measured at the carinal level
Inspiratory CO2 at 25 minutes	at=25 minutes	Inspiratory CO2, measured at the carinal level
Slope of capnography at 10 minutes (baseline)	At t=10 minutes	Angle of the D-E segment (inspiratory slope)
expiratory CO2 at 10 minutes (baseline)	at t=10 minutes	Expiratory CO2, measured at the carinal level
Slope of capnography at 25 minutes	At t=25 minutes	Angle of the D-E segment (inspiratory slope)

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	At t=45 minutes	Respiratory rate, measured by capnography
The level of HFNC dead space washout	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.

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands