Emphysema or COPDNCT03205826
Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia
A study testing Type of sedation used in people with Emphysema or COPD, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- Type of sedation used
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2018to 22 Jan 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
- Patient has provided signed informed consent.
Who cannot join
- For safety reasons patients that meet the following criteria will not be included in this study:
- FEV1 <20%
- RV/TLC>70%
- pCO2 >6.5
- RVSP>40mmHg
- 6MWT<200m
- Known intolerance to Lidocaine
- Any other medical reason/condition that warrants a short procedure (physician judgement )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia
Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature.
Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia.
Read more
Study design: This study will be a single center observational study
Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.
Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
- Conditions
- Emphysema or COPD
- Being tested
- Type of sedation used
- Keywords
- Emphysema, Bronchoscopic intervention, CHARTIS measurement
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of sedation usedOther
All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Type of sedation used | Other | All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. Receives: Other: Type of sedation used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
Measured: Baseline
Secondary outcomes (4)
Chartis measurement duration
To compare the duration of Chartis measurement in patients undergoing conscious sedation versus general anesthesia.
Measured: Baseline
Physician feasibility
To investigate qualitative assessment feasibility for the physician in patients undergoing conscious sedation or general anesthesia.
Measured: Baseline
Influence severity on outcome
To investigate the influence of severity of disease in patients undergoing conscious sedation or general anesthesia.
Measured: Baseline
Influence collateral ventilation status on outcome
To investigate outcome difference in collateral ventilation status in patients undergoing conscious sedation versus general anesthesia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Mar 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emphysema or COPDStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, d.j.slebos@umcg.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205826
- Sponsor's protocol ID
- CHARTIS sedation
- Status last verified
- Apr 2019
- First submitted
- 26 Jun 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Welling JBA, Klooster K, Hartman JE, Kerstjens HAM, Franz I, Struys MMRF, Absalom AR, Slebos DJ, Barends CRM. Collateral Ventilation Measurement Using Chartis: Procedural Sedation vs General Anesthesia. Chest. 2019 Nov;156(5):984-990. doi: 10.1016/j.chest.2019.07.025. Epub 2019 Aug 15.
PubMed 31421111
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Collateral Ventilation Using Chartis® to Select Patients With Severe Emphysema for Endobronchial Valve Treatment: Conscious Sedation Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT03205826
- Acronym / sponsor ID
- CHARTIS sedation
- Conditions
- Emphysema or COPD
- Keywords
- Emphysema, Bronchoscopic intervention, CHARTIS measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 2 Jul 2017 (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.
Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature.
Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia.
Study design: This study will be a single center observational study
Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.
Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type of sedation used | Other | Other: Type of sedation usedAll patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
- Patient has provided signed informed consent.
Key exclusion criteria (8 listed)
- For safety reasons patients that meet the following criteria will not be included in this study:
- FEV1 <20%
- RV/TLC>70%
- pCO2 >6.5
- RVSP>40mmHg
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 |
|---|---|---|
| Type of sedation usedAll patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. | Other | Type of sedation used |
Primary outcome
Failure rate
Time frame: Baseline
The failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.
4 secondary outcomes
Chartis measurement duration
Time frame: Baseline
Physician feasibility
Time frame: Baseline
Influence severity on outcome
Time frame: Baseline
Influence collateral ventilation status on outcome
Time frame: Baseline
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 17 Apr 2019.
- Derived from this study: PubMed 31421111Welling JBA, Klooster K, Hartman JE, Kerstjens HAM, Franz I, Struys MMRF, Absalom AR, Slebos DJ, Barends CRM. Collateral Ventilation Measurement Using Chartis: Procedural Sedation vs General Anesthesia. Chest. 2019 Nov;156(5):984-990. doi: 10.1016/j.chest.2019.07.025. Epub 2019 Aug 15.
- Website bronchoscopy center UMCGLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Dirk-Jan Slebos, MD PhD principal investigator
d.j.slebos@umcg.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of sedation used in people with Emphysema or COPD, run by University Medical Center Groningen 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 8 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 17 Apr 2019. 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.
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?
Failure rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205826, which also lists 1 linked publication.
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 17 Apr 2019.