Critical IllnessNCT04045262
Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume.
An observational study of Critical Illness, run by Fernando Suarez Sipmann at 1 site in Spain.
Trial summary
The aim of this study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jun 2019to 30 Mar 2022
- Phase
- Observational
- 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
Study population: Critically ill patients undergoing mechanical ventilation
Who may be able to join
- All patients on mechanical ventilation in passive breathing conditions in which a thoracic CTscan has been indicated for medical reasons and those with an EIT and a continuous cardiac monitoring
- Informed consent
Who cannot join
- Hemodynamic instability
- Presence of barotrauma/ pneumothorax
- Presence of bronchopleural fistulas
- Thorax alterations that preclude the positioning of the EIT electrode belt (usually at the IV intercostal space).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume Based on Exhaled CO2 Kinetics in Ventilated Patients.
The aim of this study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients.
Read the detailed description
The capnodinamyc method is a new monitoring method that provides continuous (breath by breath) measurements of effective pulmonary blood flow (EPBF) and effective end-expiratory l lung volume (EELVCO2). The former refers to the non-shunted fraction of cardiac output and the latter to the functional end-expiratory lung volume (EELV) that contains CO2.
The capnodynamic method is based on the advanced analysis of CO2 kinetics and the law of Conservation of mass. It states that lungs have to eliminate a similar amounts of CO2 as produced by aerobic metabolism and reaches the lung via pulmonary perfusion. For its calculation, two different measurements are needed:
- Exhaled CO2 measured by infrared optic sensor technology placed in a mainstream configuration between the endotracheal tube and the "Y" piece of the ventilator respiratory circuit.
- Flow, airway pressure and ventilatory volumes measured by the mechanical ventilator spirometer.
The method requires the generation of cyclic small changes in the alveolar concentration of CO2 which is achieved by introducing a slightly modified breathing pattern. It consists of adding a short expiratory hold in each 3 out of 9 consecutive breaths and requires the patient to be in passive breathing conditions under mechanical ventilation.
EPBF and EELVCO2 have been validated in experimental conditions and the first validations in patients in the setting of general anesthesia are under way.
Methods:
This study on EELVCO2 in critically ill patients involves 2 types of evaluations:
The validation of absolute values of EELV by comparing it with CTsan. The trending ability of EELVCO2 in critically ill patients by comparing it with EIT.
A calculated sample size of 30 patients is required for each objective.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the measurement of absolute values of effective lung volume
To validate the measurement of absolute values of effective lung volume by the capnodynamic method previously described, as an estimate of end-expiratory lung volume. For this purpose the capnodynamic method will be compared with gold standard reference method for measuring lung volumes, the computerized tomography scan (CTscan).
Measured: 1 day
Analyze to which pulmonary compartments does effective lung volume most closely correlate
Tomographic aeration level according to the density distribution analysis (non aerated, poorly aerated, normally and hyper aerated) does effective lung volume most closely correlate; taking into account that the CTscan measures an anatomic rather than a functional lung volume.
Measured: 1 day
Improvement of capnodynamic ELV measurement
To determine the effects of lung collapse on the accuracy and precision of the capnodynamic ELV measurement.
Measured: 1 day
Trending ability of the capnodynamic end-expiratory lung volume method
Breath by breath changes in EELVCO2 will be compared with breath by breath changes in lung aeration measured by electrical impedance tomography.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start4 Jun 2019
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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 Critical IllnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernando Suarez Sipmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernando Suarez Sipmann, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Fernando Suarez Sipmann, MD PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045262
- Sponsor's protocol ID
- EELVC02
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez Giralt JA, Tusman G, Wallin M, Hallback M, Perez Lucendo A, Sanchez Galindo M, Abad Santamaria B, Paz Calzada E, Garcia Garcia P, Rodriguez Huerta D, Canabal Berlanga A, Suarez-Sipmann F. Clinical validation of a capnodynamic method for measuring end-expiratory lung volume in critically ill patients. Crit Care. 2024 Apr 30;28(1):142. doi: 10.1186/s13054-024-04928-w.
PubMed 38689313
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume Based on Exhaled CO2 Kinetics in Ventilated Patients.
- ClinicalTrials.gov ID
- NCT04045262
- Acronym / sponsor ID
- EELVC02
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Fernando Suarez SipmannUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 5 Aug 2019 (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 study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients.
Detailed description
The capnodinamyc method is a new monitoring method that provides continuous (breath by breath) measurements of effective pulmonary blood flow (EPBF) and effective end-expiratory l lung volume (EELVCO2). The former refers to the non-shunted fraction of cardiac output and the latter to the functional end-expiratory lung volume (EELV) that contains CO2.
The capnodynamic method is based on the advanced analysis of CO2 kinetics and the law of Conservation of mass. It states that lungs have to eliminate a similar amounts of CO2 as produced by aerobic metabolism and reaches the lung via pulmonary perfusion. For its calculation, two different measurements are needed:
- Exhaled CO2 measured by infrared optic sensor technology placed in a mainstream configuration between the endotracheal tube and the "Y" piece of the ventilator respiratory circuit.
- Flow, airway pressure and ventilatory volumes measured by the mechanical ventilator spirometer.
The method requires the generation of cyclic small changes in the alveolar concentration of CO2 which is achieved by introducing a slightly modified breathing pattern. It consists of adding a short expiratory hold in each 3 out of 9 consecutive breaths and requires the patient to be in passive breathing conditions under mechanical ventilation.
EPBF and EELVCO2 have been validated in experimental conditions and the first validations in patients in the setting of general anesthesia are under way.
Methods:
This study on EELVCO2 in critically ill patients involves 2 types of evaluations:
The validation of absolute values of EELV by comparing it with CTsan. The trending ability of EELVCO2 in critically ill patients by comparing it with EIT.
A calculated sample size of 30 patients is required for each objective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients undergoing mechanical ventilation
Key inclusion criteria (2 listed)
- All patients on mechanical ventilation in passive breathing conditions in which a thoracic CTscan has been indicated for medical reasons and those with an EIT and a continuous cardiac monitoring
- Informed consent
Key exclusion criteria (4 listed)
- Hemodynamic instability
- Presence of barotrauma/ pneumothorax
- Presence of bronchopleural fistulas
- Thorax alterations that preclude the positioning of the EIT electrode belt (usually at the IV intercostal space).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the measurement of absolute values of effective lung volume
Time frame: 1 day
To validate the measurement of absolute values of effective lung volume by the capnodynamic method previously described, as an estimate of end-expiratory lung volume. For this purpose the capnodynamic method will be compared with gold standard reference method for measuring lung volumes, the computerized tomography scan (CTscan).
Analyze to which pulmonary compartments does effective lung volume most closely correlate
Time frame: 1 day
Tomographic aeration level according to the density distribution analysis (non aerated, poorly aerated, normally and hyper aerated) does effective lung volume most closely correlate; taking into account that the CTscan measures an anatomic rather than a functional lung volume.
Improvement of capnodynamic ELV measurement
Time frame: 1 day
To determine the effects of lung collapse on the accuracy and precision of the capnodynamic ELV measurement.
Trending ability of the capnodynamic end-expiratory lung volume method
Time frame: 1 day
Breath by breath changes in EELVCO2 will be compared with breath by breath changes in lung aeration measured by electrical impedance tomography.
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 12 Oct 2022.
- Derived from this study: PubMed 38689313Sanchez Giralt JA, Tusman G, Wallin M, Hallback M, Perez Lucendo A, Sanchez Galindo M, Abad Santamaria B, Paz Calzada E, Garcia Garcia P, Rodriguez Huerta D, Canabal Berlanga A, Suarez-Sipmann F. Clinical validation of a capnodynamic method for measuring end-expiratory lung volume in critically ill patients. Crit Care. 2024 Apr 30;28(1):142. doi: 10.1186/s13054-024-04928-w.
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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.
Fernando Suarez Sipmann, MD PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Fernando Suarez Sipmann at 1 site in Spain.
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 4 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 12 Oct 2022. 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 Spain. 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?
Validation of the measurement of absolute values of effective lung volume (time frame: 1 day). The study lists 4 primary outcomes in all. 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 NCT04045262, 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 12 Oct 2022.