Hemodynamic, MonitoringConBi-CarNCT04231656
Pulse CONtour and BIoimpedance for Measurements of Stroke Volume During Changes in CARdiac Preload
A study testing CLEARSIGHT and NICCOMO measurements in sequence A and CLEARSIGHT and NICCOMO measurements in sequence B in people with Hemodynamic, Monitoring and Anesthesia, run by University Hospital, Lille at 1 site in France.
Trial summary
Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic, Monitoring, Anesthesia, Blood Pressure
- What is being tested?
- CLEARSIGHT and NICCOMO measurements in sequence A and CLEARSIGHT and NICCOMO measurements in sequence B
- 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
- 12 Feb 2020to 7 May 2020
- 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
- Eligible and suitable for intermediate risk surgery, validated by anaesthesia consultation.
- There is no definitive definition of intermediate risk. By reference to the literature, surgeries longer than 2 hours (excluding "low risk") and less than 3% postoperative mortality (excluding high-risk surgery). It includes the majority of non-serious visceral (abdominal and gynecological) surgery, plastic or cervical-facial surgery for neoplastic removal or long-term reconstruction, or long-term spinal surgery or neurosurgery of the base of the skull.
- For which the anesthesiologist in charge has planned an invasive monitoring (radial catheter) of arterial blood pressure.
Who cannot join
- Urgent surgery
- Intracranial hypertension
- Orthostatic hypotension
- Extreme anthropometry: weight >150 kg and 30 kg, size 120 cm and >230 cm
- Related to NICCOMO monitoring:
- Rhythmic anomaly: Atrial fibrillation, tachycardia with heart rate >200 beats per minute.
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- Aortic disease: Severe sclerosis
- Valve dysfunction: severe aortic regurgitation,
- Patient with aortic prosthesis or pacemaker using impedance detection.
- Occurrence of tachycardia > 200 bpm, occurrence of hypertension with mean arterial pressure >130 mm Hg
- Simultaneous use of electrical cauterization systems during surgical procedures
- Septic shock
- Related to CLEARSIGHT monitoring
- Patient with prior distal perfusion disorders
- Lower extremity obliterans arteritis stage IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stoke Volume Measurements During Changes in Cardiac Preload: Are Pulse Contour Analysis (CLEARSIGHT) and Transthoracic Bioelectrical Impedance (NICCOMO) Equivalent?
Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other.
The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.
Read the detailed description
The main objective is to assess the concordance of two non-invasive devices using the technology described above : the Clearsight (Edwards Lifesciences, pulse contour analysis), and the Niccomo (Medis, bioimpedance). Both will be used in each patient included in the study. They will be tested during modifications of cardiac preload induced by sequences of position changes (see below) including Trendelenburg and anti-Trendelenburg positioning, performed systematically before and after the procedure, as well as during fluid challenges, vasopressor boluses and alveolar recruitment maneuvers (performed during the procedure according to the needs of the anesthesiologist in charge of the patient). Both monitors will also be compared with an invasive monitor of stroke volume (Vigileo/Flotrac, Edwards Lifesciences), and the respiratory pulse pressure variation will also be measured during the sequences of position changes and will be used as a gold standard for fluid responsiveness.
- Conditions
- Hemodynamic, Monitoring, Anesthesia, Blood Pressure
- Being tested
- CLEARSIGHT and NICCOMO measurements in sequence A, CLEARSIGHT and NICCOMO measurements in sequence B
- Keywords
- Non-invasive, Stroke volume, Cardiac preload, Interchangeability, Bioelectrical impedance, Pulse contour analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEARSIGHT and NICCOMO measurements in sequence ADevice
Also called CLEARSIGHT and NICCOMO devices (both used during each sequence)
Starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position.
CLEARSIGHT and NICCOMO measurements in sequence BDevice
Also called CLEARSIGHT and NICCOMO devices (both used during each sequence)
Starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position and collect the last group of figures.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A before sequence B | Experimental | Patients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence A of positioning (before the procedure), and sequence B after the procedure. Receives: Device: CLEARSIGHT and NICCOMO measurements in sequence A; Device: CLEARSIGHT and NICCOMO measurements in sequence B |
| Sequence B before sequence A | Experimental | Patients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence B of positioning before the procedure, and sequence A after the procedure. Receives: Device: CLEARSIGHT and NICCOMO measurements in sequence A; Device: CLEARSIGHT and NICCOMO measurements in sequence B |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance of stroke volume changes measured with each monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual).
4-quadrant plot
Measured: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
Secondary outcomes (7)
Fluid responsiveness defined by areas under the Receiver Operating Characteristic curve (sensitivity and specificity)
Comparison of areas under the Receiver Operating Characteristic curve (sensitivity and specificity). Each maneuver will be classified as "responder" or "nonresponder" according to the value of Pulse Pressure Variation (PPV) recorded before the maneuver and to the changes in PPV during the maneuver (as previously published)
Measured: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the standardized maneuvers mimicking preload decrease.
4-quadrant plot
Measured: during each changes of positioning where cardiac preload is supposed to decrease (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the standardized maneuver mimicking preload increase.
4-quadrant plot
Measured: during each changes of positioning where cardiac preload is supposed to increase (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the surgical procedure (fluid challenges, vasopressor boluses, alveolar recruitment maneuver).
4-quadrant plot
Measured: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 5-20 minutes that can occur several times during surgery
interchangeability of stroke volume measurements with each monitor during sequences A and B
Bland and Altman plot for repeated measures
Measured: before and after each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
interchangeability of stroke volume measured with each monitor during the surgical procedure (fluid challenges, vasopressor boluses, alveolar recruitment maneuver).
Bland and Altman plot for repeated measures
Measured: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed before and after sequences of 5-20 minutes that can occur several times during surgery
concordance of stroke volume changes measured with each monitor with that measured by a Vigileo/Flotrac monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual).
4-quadrant plot
Measured: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Feb 2020
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic, MonitoringStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- The primary outcome will be based on measurements performed during a sequence of position changes. Sequence A will consist of starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position. Sequence B will consist of starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position. Patients will be randomized to take sequence A before the procedure, and then the sequence B at the end of the procedure, or vice-versa (sequence B before sequence A). The randomization is not intended to compare the two groups with each other, but only to compensate for a possible"order-effect" in the execution of the maneuvers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Tavernier, MD,PhD, Principal investigator, University Hospital Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231656
- Sponsor's protocol ID
- 2019_46
- Other IDs
- 2019-A02697-50
- Acronym
- ConBi-Car
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stoke Volume Measurements During Changes in Cardiac Preload: Are Pulse Contour Analysis (CLEARSIGHT) and Transthoracic Bioelectrical Impedance (NICCOMO) Equivalent?
- ClinicalTrials.gov ID
- NCT04231656
- Acronym / sponsor ID
- ConBi-Car / 2019_46
- Conditions
- Hemodynamic, Monitoring, Anesthesia, Blood Pressure
- Keywords
- Non-invasive, Stroke volume, Cardiac preload, Interchangeability, Bioelectrical impedance, Pulse contour analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 18 Jan 2020 (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.
Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other.
The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.
Detailed description
The main objective is to assess the concordance of two non-invasive devices using the technology described above : the Clearsight (Edwards Lifesciences, pulse contour analysis), and the Niccomo (Medis, bioimpedance). Both will be used in each patient included in the study. They will be tested during modifications of cardiac preload induced by sequences of position changes (see below) including Trendelenburg and anti-Trendelenburg positioning, performed systematically before and after the procedure, as well as during fluid challenges, vasopressor boluses and alveolar recruitment maneuvers (performed during the procedure according to the needs of the anesthesiologist in charge of the patient). Both monitors will also be compared with an invasive monitor of stroke volume (Vigileo/Flotrac, Edwards Lifesciences), and the respiratory pulse pressure variation will also be measured during the sequences of position changes and will be used as a gold standard for fluid responsiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The primary outcome will be based on measurements performed during a sequence of position changes. Sequence A will consist of starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position. Sequence B will consist of starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position. Patients will be randomized to take sequence A before the procedure, and then the sequence B at the end of the procedure, or vice-versa (sequence B before sequence A). The randomization is not intended to compare the two groups with each other, but only to compensate for a possible"order-effect" in the execution of the maneuvers.
| Arm | Type | Receives |
|---|---|---|
| Sequence A before sequence B | Experimental | Device: CLEARSIGHT and NICCOMO measurements in sequence A, Device: CLEARSIGHT and NICCOMO measurements in sequence BPatients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence A of positioning (before the procedure), and sequence B after the procedure. |
| Sequence B before sequence A | Experimental | Device: CLEARSIGHT and NICCOMO measurements in sequence A, Device: CLEARSIGHT and NICCOMO measurements in sequence BPatients eligible for intermediate risk surgery requiring the placement of an invasive continuous blood pressure measurement device and stroke volume monitoring for fluid management. Sequence B of positioning before the procedure, and sequence A after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible and suitable for intermediate risk surgery, validated by anaesthesia consultation.
- There is no definitive definition of intermediate risk. By reference to the literature, surgeries longer than 2 hours (excluding "low risk") and less than 3% postoperative mortality (excluding high-risk surgery). It includes the majority of non-serious visceral (abdominal and gynecological) surgery, plastic or cervical-facial surgery for neoplastic removal or long-term reconstruction, or long-term spinal surgery or neurosurgery of the base of the skull.
- For which the anesthesiologist in charge has planned an invasive monitoring (radial catheter) of arterial blood pressure.
Key exclusion criteria (15 listed)
- Urgent surgery
- Intracranial hypertension
- Orthostatic hypotension
- Extreme anthropometry: weight >150 kg and 30 kg, size 120 cm and >230 cm
- Related to NICCOMO monitoring:
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 |
|---|---|---|
| CLEARSIGHT and NICCOMO measurements in sequence AAlso: CLEARSIGHT and NICCOMO devices (both used during each sequence)Starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position. | Device | Sequence A before sequence B, Sequence B before sequence A |
| CLEARSIGHT and NICCOMO measurements in sequence BAlso: CLEARSIGHT and NICCOMO devices (both used during each sequence)Starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position and collect the last group of figures. | Device | Sequence A before sequence B, Sequence B before sequence A |
Primary outcome
concordance of stroke volume changes measured with each monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual).
Time frame: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
4-quadrant plot
7 secondary outcomes
Fluid responsiveness defined by areas under the Receiver Operating Characteristic curve (sensitivity and specificity)
Time frame: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the standardized maneuvers mimicking preload decrease.
Time frame: during each changes of positioning where cardiac preload is supposed to decrease (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the standardized maneuver mimicking preload increase.
Time frame: during each changes of positioning where cardiac preload is supposed to increase (i.e., for 1-2 minutes in one out of two condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
concordance of stroke volume changes measured with each monitor during the surgical procedure (fluid challenges, vasopressor boluses, alveolar recruitment maneuver).
Time frame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 5-20 minutes that can occur several times during surgery
interchangeability of stroke volume measurements with each monitor during sequences A and B
Time frame: before and after each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
interchangeability of stroke volume measured with each monitor during the surgical procedure (fluid challenges, vasopressor boluses, alveolar recruitment maneuver).
Time frame: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed before and after sequences of 5-20 minutes that can occur several times during surgery
concordance of stroke volume changes measured with each monitor with that measured by a Vigileo/Flotrac monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual).
Time frame: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B
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 21 Apr 2021.
- 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.
Benoit Tavernier, MD,PhD principal investigator
University Hospital Lille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLEARSIGHT and NICCOMO measurements in sequence A and CLEARSIGHT and NICCOMO measurements in sequence B in people with Hemodynamic, Monitoring and Anesthesia, run by University Hospital, Lille 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 21 Apr 2021. 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?
concordance of stroke volume changes measured with each monitor during the standardized maneuvers of sequences A and B (total: 6 observations per individual). (time frame: during each changes of positioning (i.e., for 1-2 minutes in each condition, for a total of 10-15 minutes following initial measurements in basal conditions), during sequences A and B). 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 21 Apr 2021.