Ventilatory Effects of THRIVE During EBUS

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercapnia; Sedation Complication; High Flow Nasal Cannula
• Intervention / Treatment: Device: THRIVE (High Flow Nasal Cannula)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 30 L - 70 L; 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.	Device: THRIVE (High Flow Nasal Cannula); 2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen; Other Names: Optiflow; High Flow Nasal Cannula; THRIVE; High Flow Nasal Oxygen
Active Comparator: 70 L - 30 L; 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.	Device: THRIVE (High Flow Nasal Cannula); 2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen; Other Names: Optiflow; High Flow Nasal Cannula; THRIVE; High Flow Nasal Oxygen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Respiratory rate, measured by capnography	At t=10 minutes
Respiratory rate	Respiratory rate, measured by capnography	At t=25 minutes
Respiratory rate	Respiratory rate, measured by capnography	At t=45 minutes
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
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
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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Jeffrey Miechels, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem; Study Chair: Mark V Koning, MD, PhD, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem; Study Director: Niels Claessens, MD, PhD, Dept. of Pulmonology, Rijnstate Hospital, Arnhem

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Sedation; High Flow Nasal Cannula; Dead space ventilation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2022-2031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request and within the limits of the law on patient data distribution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No