HypercapniaPhase 3NCT05505279
Ventilatory Effects of THRIVE During EBUS
A Phase 3 study testing THRIVE (High Flow Nasal Cannula) in people with Hypercapnia and Sedation Complication, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnia, Sedation Complication, High Flow Nasal Cannula
- What is being tested?
- THRIVE (High Flow Nasal Cannula)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Oct 2022to 8 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with COPD Gold classification 3 or 4
- Scheduled EBUS with sedation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypercapnia, Sedation Complication, High Flow Nasal Cannula
- Being tested
- THRIVE (High Flow Nasal Cannula)
- Keywords
- High Flow Nasal Cannula, Sedation, Dead space ventilation
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE (High Flow Nasal Cannula)Device
Also called THRIVE, Optiflow, High Flow Nasal Cannula, High Flow Nasal Oxygen
2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen
| Study group | Role | What they receive |
|---|---|---|
| 30 L - 70 L | Active comparator | 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. Receives: Device: THRIVE (High Flow Nasal Cannula) |
| 70 L - 30 L | Active comparator | 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. Receives: Device: THRIVE (High Flow Nasal Cannula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory CO2 at 10 minutes (baseline)
Inspiratory CO2, measured at the carinal level
Measured: at t=10 minutes
Inspiratory CO2 at 25 minutes
Inspiratory CO2, measured at the carinal level
Measured: at=25 minutes
Inspiratory CO2 at 45 minutes
Inspiratory CO2, measured at the carinal level
Measured: at t=45 minutes
expiratory CO2 at 10 minutes (baseline)
Expiratory CO2, measured at the carinal level
Measured: at t=10 minutes
expiratory CO2 at 25 minutes
Expiratory CO2, measured at the carinal level
Measured: at t=25 minutes
expiratory CO2 at 45 minutes
Expiratory CO2, measured at the carinal level
Measured: t=45 minutes
Slope of capnography at 10 minutes (baseline)
Angle of the D-E segment (inspiratory slope)
Measured: At t=10 minutes
Slope of capnography at 25 minutes
Angle of the D-E segment (inspiratory slope)
Measured: At t=25 minutes
Slope of capnography at 45 minutes
Angle of the D-E segment (inspiratory slope)
Measured: At t=45 minutes
Secondary outcomes (6)
Respiratory rate
Respiratory rate, measured by capnography
Measured: At t=10 minutes
Respiratory rate
Respiratory rate, measured by capnography
Measured: At t=25 minutes
Respiratory rate
Respiratory rate, measured by capnography
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At t=45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start5 Oct 2022
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Jeffrey Miechels, Principal investigator, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, ArnhemMark V Koning, MD, PhD, Study chair, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, ArnhemNiels Claessens, MD, PhD, Study director, Dept. of Pulmonology, Rijnstate Hospital, Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505279
- Sponsor's protocol ID
- 2022-2031
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request and within the limits of the law on patient data distribution.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?
- ClinicalTrials.gov ID
- NCT05505279
- Acronym / sponsor ID
- 2022-2031
- Conditions
- Hypercapnia, Sedation Complication, High Flow Nasal Cannula
- Keywords
- High Flow Nasal Cannula, Sedation, Dead space ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 L - 70 L | Active comparator | Device: 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 | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with COPD Gold classification 3 or 4
- Scheduled EBUS with sedation
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE (High Flow Nasal Cannula)Also: THRIVE, Optiflow, High Flow Nasal Cannula, High Flow Nasal Oxygen2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen | Device | 30 L - 70 L, 70 L - 30 L |
Primary outcome
Inspiratory CO2 at 10 minutes (baseline)
Time frame: at t=10 minutes
Inspiratory CO2, measured at the carinal level
Inspiratory CO2 at 25 minutes
Time frame: at=25 minutes
Inspiratory CO2, measured at the carinal level
Inspiratory CO2 at 45 minutes
Time frame: at t=45 minutes
Inspiratory CO2, measured at the carinal level
expiratory CO2 at 10 minutes (baseline)
Time frame: at t=10 minutes
Expiratory CO2, measured at the carinal level
expiratory CO2 at 25 minutes
Time frame: at t=25 minutes
Expiratory CO2, measured at the carinal level
expiratory CO2 at 45 minutes
Time frame: t=45 minutes
Expiratory CO2, measured at the carinal level
Slope of capnography at 10 minutes (baseline)
Time frame: At t=10 minutes
Angle of the D-E segment (inspiratory slope)
Slope of capnography at 25 minutes
Time frame: At t=25 minutes
Angle of the D-E segment (inspiratory slope)
Slope of capnography at 45 minutes
Time frame: At t=45 minutes
Angle of the D-E segment (inspiratory slope)
6 secondary outcomes
Respiratory rate
Time frame: At t=10 minutes
Respiratory rate
Time frame: At t=25 minutes
Respiratory rate
Time frame: At t=45 minutes
The level of HFNC dead space washout
Time frame: At t=10 minutes
The level of HFNC dead space washout
Time frame: At t=25 minutes
The level of HFNC dead space washout
Time frame: At t=45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request and within the limits of the law on patient data distribution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Miechels principal investigator
Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
Mark V Koning, MD, PhD study chair
Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
Niels Claessens, MD, PhD study director
Dept. of Pulmonology, Rijnstate Hospital, Arnhem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing THRIVE (High Flow Nasal Cannula) in people with Hypercapnia and Sedation Complication, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory CO2 at 10 minutes (baseline) (time frame: at t=10 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.