Ventilator LungELVISNCT03501446
A Pilot Validation Study of Continuous CO2-based End-expiratory Lung Volume Measurements in Humans.
An observational study of Ventilator Lung and Gas Exchange, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The capnodynamic method non-invasively calculates effective lung volume (ELV) continuously during surgery. In this study ELV is compared to functionalresidual capacity (FRC) measured with Nitrogen Multiple Breath Wash out (NMBW) at 0 and 5 cm H2O Positive End Expiratory Pressure (PEEP) in patients scheduled for neck… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Lung, Gas Exchange, Pulmonary Function
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2014to 21 Oct 2015
- 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: Individuals scheduled for neck surgery at Karolinska university hospital
Who may be able to join
- Individuals without current heart or lung disease
Who cannot join
- Obesitas
- Heart disease
- Lung disease
- Current smoker
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital
Solna, Stockholm County, SE-171 76
About this study
Official title: A Pilot Validation Study of Continuous CO2-based End-expiratory Lung Volume Measurements in Humans and an Experimental Porcine Model.
The capnodynamic method non-invasively calculates effective lung volume (ELV) continuously during surgery. In this study ELV is compared to functionalresidual capacity (FRC) measured with Nitrogen Multiple Breath Wash out (NMBW) at 0 and 5 cm H2O Positive End Expiratory Pressure (PEEP) in patients scheduled for neck surgery at the Karolinska University Hospital, Solna, Sweden.
Read the detailed description
The capnodynamic method continuously calculates effective lung volume (ELV) with the help of a capnodynamic equation:
ELV x (FACO2(n) - FACO2(n-1)) = delta t(n) x EPBF (CvCO2 - CvCO2(n)) - VTCO2. ELV Effective lung volume [L]. EPBF Effective pulmonary blood flow [L/min]. n current breath. n-1 previous breath. FACO2 mean alveolar carbon dioxide fraction. CvCO2 mixed venous carbon dioxide content [Lgas/Lblood]. CcCO2n pulmonary end-capillary carbon dioxide content [Lgas/Lblood]. VTCO2n volume [L] of carbon dioxide eliminated by the current, nth, breath. delta t n current breath cycle time [min]. The equation above describes the mole balance between the CO2 delivered to lungs (EPBF), the volume taking part in the gas exchange (ELV) and CO2 excreted from the lungs (VTCO2). Normally there is no difference in CO2 between the actual and the preceding breath as the same amount of CO2 as delivered to the lungs as is excreted. When small changes in CO2 concentration are inserted into the equation obtained with short inspiratory pauses in three out of nine breaths, nine different equations are obtained. The three unknown variables; ELV, EPBF and CvCO2 can be solved with a linear least square optimization, a well-known numerical mathematical principle. The breathing pattern is automatically controlled by the ventilator which provides continuous calculations of ELV where each value represents the average of the preceding nine breaths and renews with each breath as the newest replaces the oldest in the equation system.
At the day of surgery, included patients arrive at the surgical unit. After safe surgical checklist, vital signs are measured patients are anesthetized and muscle relaxed per routine practice. An endotracheal tube is inserted in the trachea and the patient connected to a ventilator. Anesthesia is maintained with Propofol in target controlled infusion and a short acting opioid is added as needed.
The protocol comprises a measurement of functional residual capacity (FRC) with the reference method, nitrogen multiple breath wash out (NMBW), at 0 cm H2O Positive End Expiratory Pressure (PEEP). The tracheal tube is then connected to the Servo-i ventilator with the capnodynamic breathing pattern applied. An ELV measurement at PEEP 0 cm H2O is followed by a measurement of ELV at PEEP 10 cm H2O and lastly a measurement of ELV at PEEP 5 cm H2O before the tube is clamped and connected to the NMBW reference method ventilator again for a measurement of FRC at PEEP 5 cm H2O.
The attending anesthesiologist has the final responsibility of the patient and could at any time end the protocol if needed.
- Conditions
- Ventilator Lung, Gas Exchange, Pulmonary Function
- Keywords
- PEEP optimization, Lung volumes
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective lung volume
Lung volume measurements during mechanical ventilation based on CO2 dynamics and a differentiated Fick's principle.
Measured: Continous measurements during general anaesthesia and mechanical ventialtion, 45 minutes-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Dec 2014
- Primary completion21 Oct 2015
- Study completion21 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Öhman, Karolinska Institutet
- Investigators
- Håkan Björne, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501446
- Sponsor's protocol ID
- 2014/1393-31/2
- Acronym
- ELVIS
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Validation Study of Continuous CO2-based End-expiratory Lung Volume Measurements in Humans and an Experimental Porcine Model.
- ClinicalTrials.gov ID
- NCT03501446
- Acronym / sponsor ID
- ELVIS / 2014/1393-31/2
- Conditions
- Ventilator Lung, Gas Exchange, Pulmonary Function
- Keywords
- PEEP optimization, Lung volumes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 21 Oct 2015 (actual)
- Study completion
- 21 Oct 2015 (actual)
- First posted
- 18 Apr 2018 (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 capnodynamic method non-invasively calculates effective lung volume (ELV) continuously during surgery. In this study ELV is compared to functionalresidual capacity (FRC) measured with Nitrogen Multiple Breath Wash out (NMBW) at 0 and 5 cm H2O Positive End Expiratory Pressure (PEEP) in patients scheduled for neck surgery at the Karolinska University Hospital, Solna, Sweden.
Detailed description
The capnodynamic method continuously calculates effective lung volume (ELV) with the help of a capnodynamic equation:
ELV x (FACO2(n) - FACO2(n-1)) = delta t(n) x EPBF (CvCO2 - CvCO2(n)) - VTCO2. ELV Effective lung volume [L]. EPBF Effective pulmonary blood flow [L/min]. n current breath. n-1 previous breath. FACO2 mean alveolar carbon dioxide fraction. CvCO2 mixed venous carbon dioxide content [Lgas/Lblood]. CcCO2n pulmonary end-capillary carbon dioxide content [Lgas/Lblood]. VTCO2n volume [L] of carbon dioxide eliminated by the current, nth, breath. delta t n current breath cycle time [min]. The equation above describes the mole balance between the CO2 delivered to lungs (EPBF), the volume taking part in the gas exchange (ELV) and CO2 excreted from the lungs (VTCO2). Normally there is no difference in CO2 between the actual and the preceding breath as the same amount of CO2 as delivered to the lungs as is excreted. When small changes in CO2 concentration are inserted into the equation obtained with short inspiratory pauses in three out of nine breaths, nine different equations are obtained. The three unknown variables; ELV, EPBF and CvCO2 can be solved with a linear least square optimization, a well-known numerical mathematical principle. The breathing pattern is automatically controlled by the ventilator which provides continuous calculations of ELV where each value represents the average of the preceding nine breaths and renews with each breath as the newest replaces the oldest in the equation system.
At the day of surgery, included patients arrive at the surgical unit. After safe surgical checklist, vital signs are measured patients are anesthetized and muscle relaxed per routine practice. An endotracheal tube is inserted in the trachea and the patient connected to a ventilator. Anesthesia is maintained with Propofol in target controlled infusion and a short acting opioid is added as needed.
The protocol comprises a measurement of functional residual capacity (FRC) with the reference method, nitrogen multiple breath wash out (NMBW), at 0 cm H2O Positive End Expiratory Pressure (PEEP). The tracheal tube is then connected to the Servo-i ventilator with the capnodynamic breathing pattern applied. An ELV measurement at PEEP 0 cm H2O is followed by a measurement of ELV at PEEP 10 cm H2O and lastly a measurement of ELV at PEEP 5 cm H2O before the tube is clamped and connected to the NMBW reference method ventilator again for a measurement of FRC at PEEP 5 cm H2O.
The attending anesthesiologist has the final responsibility of the patient and could at any time end the protocol if needed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals scheduled for neck surgery at Karolinska university hospital
Key inclusion criteria (1 listed)
- Individuals without current heart or lung disease
Key exclusion criteria (4 listed)
- Obesitas
- Heart disease
- Lung disease
- Current smoker
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
Effective lung volume
Time frame: Continous measurements during general anaesthesia and mechanical ventialtion, 45 minutes-2 hours
Lung volume measurements during mechanical ventilation based on CO2 dynamics and a differentiated Fick's principle.
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 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Håkan Björne, PhD study director
Karolinska Institutet
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 Ventilator Lung and Gas Exchange, run by Karolinska Institutet at 1 site in Sweden.
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 1 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 18 Apr 2018. 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 Sweden. 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?
Effective lung volume (time frame: Continous measurements during general anaesthesia and mechanical ventialtion, 45 minutes-2 hours). 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 18 Apr 2018.