COPDEval 3V-BPCONCT05953298
Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Electrical impedance tomography (EIT) in people with COPD, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Electrical impedance tomography (EIT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2023to 28 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital;
- Patient benefiting from social protection from the national health insurance fund;
- Patient having read the patient information letter and given his non-objection to participate in the study.
Who cannot join
- Obesity with a BMI > 35;
- Respiratory exacerbation during treatment;
- Patient with one or more contraindications to the implementation of EIT(7):
- Pacemaker, defibrillator, electric active medical device;
- Damaged skin condition, dressing on the observation area;
- Risk related to fitting the belt (fracture, spinal lesions, etc.);
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- Uncontrollable movements;
- Current electrotherapy;
- Presence of a magnetic field (magnetic resonance imaging);
- Other bioimpedance measurements in progress;
- Pregnant woman ;
- Tidal volume < 1ml/kg;
- Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3);
- Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision;
- Patient included in other protocols that may interact with this study;
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Haut Lévêque, Centre Hospitalier Universitaire de Bordeaux
Pessac, 33600
About this study
Official title: Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD
The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.
Read the detailed description
In patients with COPD, European recommendations recommend the use of NIV with a "high pressure" setting (1). These ventilatory modalities go against what is done in acute. Indeed, in this case, the pressures are much lower, because the risk of asynchronies and dynamic hyperinflation under NIV is then very important.
The usual techniques for evaluating lung volume and dynamic hyperinflation do not allow this to be measured under NIV.
Assessing lung volumes under NIV in stable COPD patients is therefore of major interest in understanding the impact of "high-intensity" ventilation.
Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level.(2) Among these measures, the End-Expiratory Lung Impedance (EELI), strongly correlated to the End-Expiratory Lung Volume (EELV), is the reflection of the FRC and can be dynamically monitored in real time at the patient's bedside(3). However, it has never been used in stable COPD patients on NIV, and could be an interesting tool for analyzing the impact of NIV on lung volumes.
The main objective is to evaluate the variation of EELV reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography, during a 20-minute session of NIV in patients with COPD at the stable state
The secondary objectives will be:
- To evaluate the variation of the EELV reflecting the FRC, via the EELI obtained by electrical impedance tomography, before, during and after a 20-minute session of NIV in stable-state COPD patients.
- Evaluate the relationship between the variation of PtCO2, and that of EELV under NIV, reflection of the FRC, via the EELI obtained by electrical impedance tomography.
- Identify responder and non-responder patient subgroups.
- Conditions
- COPD
- Being tested
- Electrical impedance tomography (EIT)
- Keywords
- Chronic obstructive pulmonary disease, non invasive ventilation, end-expiratory lung volume, electrical impedance tomography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography (EIT)Device
Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Experimental | Patients with COPD in stable condition fitted with long-term NIV Receives: Device: Electrical impedance tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions
End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1*100
Measured: Day 1
Secondary outcomes (2)
End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions
A secondary objective of this research is to observe the evolution of the EELI before, during and after the NIV. In this context, the reference value will be the measurement of the EELI before the NIV, i.e. EELIT0. Thus the EELI values at T1 (NIV initiation+1 minute), T2 (NIV+20minutes) and T3 (5minutes after NIV) will be presented as a percentage change compared to T0 and will be respectively ∆EELI%T1, ∆EELI %T2 and ∆EELI%T3, respecting the following calculation: ∆EELI%Tx = (EELIT0-EELITx)/EELIT0*100.
Measured: Day 1
Transcutaneous capnia
A secondary objective of this research is to observe the evolution of transcutaneous capnia (PtCO2) in mmHg via a capnograph before (T0), during (T1, T2) and after NIV (T3).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start26 Jun 2023
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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 Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leo GRASSION, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953298
- Sponsor's protocol ID
- CHUBX 2023/10
- Acronym
- Eval 3V-BPCO
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz SB, Magnet FS, Windisch W. Why High-Intensity NPPV is Favourable to Low-Intensity NPPV: Clinical and Physiological Reasons. COPD. 2017 Aug;14(4):389-395. doi: 10.1080/15412555.2017.1318843. Epub 2017 May 11.
PubMed 28494170Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161Hinz J, Hahn G, Neumann P, Sydow M, Mohrenweiser P, Hellige G, Burchardi H. End-expiratory lung impedance change enables bedside monitoring of end-expiratory lung volume change. Intensive Care Med. 2003 Jan;29(1):37-43. doi: 10.1007/s00134-002-1555-4. Epub 2002 Nov 20.
PubMed 12528020Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
PubMed 27997805
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD
- ClinicalTrials.gov ID
- NCT05953298
- Acronym / sponsor ID
- Eval 3V-BPCO / CHUBX 2023/10
- Conditions
- COPD
- Keywords
- Chronic obstructive pulmonary disease, non invasive ventilation, end-expiratory lung volume, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 20 Jul 2023 (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.
The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.
Detailed description
In patients with COPD, European recommendations recommend the use of NIV with a "high pressure" setting (1). These ventilatory modalities go against what is done in acute. Indeed, in this case, the pressures are much lower, because the risk of asynchronies and dynamic hyperinflation under NIV is then very important.
The usual techniques for evaluating lung volume and dynamic hyperinflation do not allow this to be measured under NIV.
Assessing lung volumes under NIV in stable COPD patients is therefore of major interest in understanding the impact of "high-intensity" ventilation.
Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level.(2) Among these measures, the End-Expiratory Lung Impedance (EELI), strongly correlated to the End-Expiratory Lung Volume (EELV), is the reflection of the FRC and can be dynamically monitored in real time at the patient's bedside(3). However, it has never been used in stable COPD patients on NIV, and could be an interesting tool for analyzing the impact of NIV on lung volumes.
The main objective is to evaluate the variation of EELV reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography, during a 20-minute session of NIV in patients with COPD at the stable state
The secondary objectives will be:
- To evaluate the variation of the EELV reflecting the FRC, via the EELI obtained by electrical impedance tomography, before, during and after a 20-minute session of NIV in stable-state COPD patients.
- Evaluate the relationship between the variation of PtCO2, and that of EELV under NIV, reflection of the FRC, via the EELI obtained by electrical impedance tomography.
- Identify responder and non-responder patient subgroups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | Experimental | Device: Electrical impedance tomography (EIT)Patients with COPD in stable condition fitted with long-term NIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital;
- Patient benefiting from social protection from the national health insurance fund;
- Patient having read the patient information letter and given his non-objection to participate in the study.
Key exclusion criteria (15 listed)
- Obesity with a BMI > 35;
- Respiratory exacerbation during treatment;
- Patient with one or more contraindications to the implementation of EIT(7):
- Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3);
- Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision;
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 |
|---|---|---|
| Electrical impedance tomography (EIT)Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level | Device | Patients with COPD |
Primary outcome
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions
Time frame: Day 1
End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1*100
2 secondary outcomes
End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions
Time frame: Day 1
Transcutaneous capnia
Time frame: Day 1
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 26 Jun 2024.
- Background: PubMed 28494170Schwarz SB, Magnet FS, Windisch W. Why High-Intensity NPPV is Favourable to Low-Intensity NPPV: Clinical and Physiological Reasons. COPD. 2017 Aug;14(4):389-395. doi: 10.1080/15412555.2017.1318843. Epub 2017 May 11.
- Background: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Background: PubMed 12528020Hinz J, Hahn G, Neumann P, Sydow M, Mohrenweiser P, Hellige G, Burchardi H. End-expiratory lung impedance change enables bedside monitoring of end-expiratory lung volume change. Intensive Care Med. 2003 Jan;29(1):37-43. doi: 10.1007/s00134-002-1555-4. Epub 2002 Nov 20.
- Background: PubMed 27997805Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
- Individual participant dataSharing planned: No
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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.
Leo GRASSION, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical impedance tomography (EIT) in people with COPD, run by University Hospital, Bordeaux at 1 site in France.
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 3 inclusion and 15 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 26 Jun 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 France. 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?
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions (time frame: Day 1). 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 NCT05953298, which also lists 4 linked publications.
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 26 Jun 2024.