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Ventilatory Effects of THRIVE During EBUS

Primary Purpose

Hypercapnia, Sedation Complication, High Flow Nasal Cannula

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
THRIVE (High Flow Nasal Cannula)
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypercapnia focused on measuring High Flow Nasal Cannula, Sedation, Dead space ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rijnstate HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

30 L - 70 L

70 L - 30 L

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory rate
Respiratory rate, measured by capnography
Respiratory rate
Respiratory rate, measured by capnography
Respiratory rate
Respiratory rate, measured by capnography
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.
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.
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.

Full Information

First Posted
August 10, 2022
Last Updated
October 10, 2022
Sponsor
Rijnstate Hospital
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05505279
Brief Title
Ventilatory Effects of THRIVE During EBUS
Official Title
Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
Fisher and Paykel Healthcare

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia, Sedation Complication, High Flow Nasal Cannula
Keywords
High Flow Nasal Cannula, Sedation, Dead space ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
30 L - 70 L
Arm Type
Active Comparator
Arm Description
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.
Arm Title
70 L - 30 L
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
THRIVE (High Flow Nasal Cannula)
Other Intervention Name(s)
THRIVE, Optiflow, High Flow Nasal Cannula, High Flow Nasal Oxygen
Intervention Description
2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen
Primary Outcome Measure Information:
Title
Inspiratory CO2 at 10 minutes (baseline)
Description
Inspiratory CO2, measured at the carinal level
Time Frame
at t=10 minutes
Title
Inspiratory CO2 at 25 minutes
Description
Inspiratory CO2, measured at the carinal level
Time Frame
at=25 minutes
Title
Inspiratory CO2 at 45 minutes
Description
Inspiratory CO2, measured at the carinal level
Time Frame
at t=45 minutes
Title
expiratory CO2 at 10 minutes (baseline)
Description
Expiratory CO2, measured at the carinal level
Time Frame
at t=10 minutes
Title
expiratory CO2 at 25 minutes
Description
Expiratory CO2, measured at the carinal level
Time Frame
at t=25 minutes
Title
expiratory CO2 at 45 minutes
Description
Expiratory CO2, measured at the carinal level
Time Frame
t=45 minutes
Title
Slope of capnography at 10 minutes (baseline)
Description
Angle of the D-E segment (inspiratory slope)
Time Frame
At t=10 minutes
Title
Slope of capnography at 25 minutes
Description
Angle of the D-E segment (inspiratory slope)
Time Frame
At t=25 minutes
Title
Slope of capnography at 45 minutes
Description
Angle of the D-E segment (inspiratory slope)
Time Frame
At t=45 minutes
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
Respiratory rate, measured by capnography
Time Frame
At t=10 minutes
Title
Respiratory rate
Description
Respiratory rate, measured by capnography
Time Frame
At t=25 minutes
Title
Respiratory rate
Description
Respiratory rate, measured by capnography
Time Frame
At t=45 minutes
Title
The level of HFNC dead space washout
Description
Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.
Time Frame
At t=10 minutes
Title
The level of HFNC dead space washout
Description
Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.
Time Frame
At t=25 minutes
Title
The level of HFNC dead space washout
Description
Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.
Time Frame
At t=45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Miechels
Phone
0031-88-0058888
Email
jmiechels@rijnstate.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mark V Koning, MD, PhD
Phone
0031-88-0058888
Email
MVKoning@rijnstate.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Miechels
Organizational Affiliation
Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark V Koning, MD, PhD
Organizational Affiliation
Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Niels Claessens, MD, PhD
Organizational Affiliation
Dept. of Pulmonology, Rijnstate Hospital, Arnhem
Official's Role
Study Director
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Miechels
Email
jmiechels@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Mark V Koning, MD, PhD
Email
MVKoning@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Niels Claessens, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request and within the limits of the law on patient data distribution.

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Ventilatory Effects of THRIVE During EBUS

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