Aortic AneurysmNCT02630550
Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study
An observational study of Aortic Aneurysm and Peripheral Arterial Disease, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Aneurysm, Peripheral Arterial Disease
- What is being tested?
- Cheetah NICOM and Transesophageal echocardiography (TEE)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Oct 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing either an open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
Who may be able to join
- Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
- ASA 1-3
Who cannot join
- Refuses general anesthesia
- Contraindication to transesophageal echocardiography
- Allergy to the glue of the Cheetah NICOM probes
- Severe aortic valve regurgitation
- Thoracic aorta anatomy anomaly
- Unipolar pacemaker
Trial locations and contacts
1 site in 1 country.
Eric Peters contact
Nadia Godin, RN contact
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Nadia Godin, RN, 252-3400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
Louis-Philippe Fortier, MSc,MD
About this study
The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. The present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. The measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. The validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output.
- Conditions
- Aortic Aneurysm, Peripheral Arterial Disease
- Being tested
- Cheetah NICOM, Transesophageal echocardiography (TEE)
- Keywords
- Cardiac output, Intraoperative Monitoring, Echocardiography, Transesophageal, Vascular cross-clamping, Endarterectomy, Monitoring, Physiologic/instrumentation, Cardiography, Impedance
- Medical subject headings
- Aortic Aneurysm, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheetah NICOMDevice
The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.
Transesophageal echocardiography (TEE)Device
TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Aneurysm Repair | The impact of large abdominal retractors and an abdominal aortic cross-clamp on the validity of the Cheetah NICOM's measurements will be evaluated in this group. Receives: Device: Cheetah NICOM; Device: Transesophageal echocardiography (TEE) | |
| Femoral Endarterectomy | The impact of the clamping of a large peripheral arterial vessel on the validity of the Cheetah NICOM's measurements will be evaluated in this group. Receives: Device: Cheetah NICOM; Device: Transesophageal echocardiography (TEE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM
The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple time points during the surgery.
Measured: Per vascular surgery procedure
Secondary outcomes (2)
Stroke Volume (SV) with a vascular cross-clamp
The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple points once a vascular cross-clamp is installed.
Measured: Per vascular surgery procedure when a cross-clamp is installed
Stroke Volume (SV) trending ability
Between each pair of consecutive data points, the change of SV measurements given by the Cheetah NICOM will be compared to those given by transesophageal echocardiography.
Measured: Per vascular surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital
- Investigators
- Louis-Philippe Fortier, MD, MSc, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630550
- Sponsor's protocol ID
- 15042
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Cheetah NICOM by Comparison to TEE During Open Vascular Surgery - Pilot Study
- ClinicalTrials.gov ID
- NCT02630550
- Acronym / sponsor ID
- 15042
- Conditions
- Aortic Aneurysm, Peripheral Arterial Disease
- Keywords
- Cardiac output, Intraoperative Monitoring, Echocardiography, Transesophageal, Vascular cross-clamping, Endarterectomy, Monitoring, Physiologic/instrumentation, Cardiography, Impedance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- 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 Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. The present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. The measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. The validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Aneurysm Repair | – | Device: Cheetah NICOM, Device: Transesophageal echocardiography (TEE)The impact of large abdominal retractors and an abdominal aortic cross-clamp on the validity of the Cheetah NICOM's measurements will be evaluated in this group. |
| Femoral Endarterectomy | – | Device: Cheetah NICOM, Device: Transesophageal echocardiography (TEE)The impact of the clamping of a large peripheral arterial vessel on the validity of the Cheetah NICOM's measurements will be evaluated in this group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing either an open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
Key inclusion criteria (2 listed)
- Patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia.
- ASA 1-3
Key exclusion criteria (6 listed)
- Refuses general anesthesia
- Contraindication to transesophageal echocardiography
- Allergy to the glue of the Cheetah NICOM probes
- Severe aortic valve regurgitation
- Thoracic aorta anatomy anomaly
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 |
|---|---|---|
| Cheetah NICOMThe Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements. | Device | Aortic Aneurysm Repair, Femoral Endarterectomy |
| Transesophageal echocardiography (TEE)TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM. | Device | Aortic Aneurysm Repair, Femoral Endarterectomy |
Primary outcome
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM
Time frame: Per vascular surgery procedure
The SV measured by the Cheetah NICOM will be compared to the one measured by transesophageal echocardiography at multiple time points during the surgery.
2 secondary outcomes
Stroke Volume (SV) with a vascular cross-clamp
Time frame: Per vascular surgery procedure when a cross-clamp is installed
Stroke Volume (SV) trending ability
Time frame: Per vascular surgery procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
Eric Peters contact
Nadia Godin, RN contact
Louis-Philippe Fortier, MD, MSc principal investigator
Maisonneuve-Rosemont Hospital
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 Aortic Aneurysm and Peripheral Arterial Disease, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Dec 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Peters (514-252-3400), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Stroke Volume (SV) Measurements by the Cheetah NICOM (time frame: Per vascular surgery procedure). 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 15 Dec 2015.