Fluid OverloadNICOMNCT02813915
Non-invasive Cardiac Output Monitor in Young Adults
An observational study of Fluid Overload and Hypovolemia, run by Indiana University.
Trial summary
The investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Fluid Overload, Hypovolemia
- What is being tested?
- NICOM
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2016to 1 Mar 2018
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients 18-30 years of age having surgery at Riley or University Hospital
Who may be able to join
- 18 -30 years of age
- presenting for surgery at Riley or University Hospital
Who cannot join
- younger than 18
- severely mentally handicapped
- orthopedic cases with leg injuries
- any other contraindications that would prevent or discourage passive leg raises
- if deemed ineligible by an investigator for any other reason.
About this study
Official title: A Trial of a Non-Invasive Cardiac Output in Young Adults
The investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with routine monitoring will provide a better assessment of intra-operative status.
Read the detailed description
This study will involve measurements of cardiac output, stroke volume, and fluid responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before and after anesthesia induction.
- Conditions
- Fluid Overload, Hypovolemia
- Being tested
- NICOM
- Keywords
- cardiac monitoring, Cheetah Medical, passive leg raises
- Medical subject headings
- Edema, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICOMDevice
Use of NICOM and PLR to obtain patient fluid status
| Study group | Role | What they receive |
|---|---|---|
| Use of Cheetah medical NICOM | For those who consent to the study, the Cheetah NICOM will be used to obtain cardiac output, stroke volume, and fluid responsiveness. Receives: Device: NICOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Fluid responsiveness
If patient is fluid responsive, Stroke Volume Index (SVI) will increase by 10% or greater compared to its baseline
Measured: within 30 minutes post-anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start17 Jul 2016
- Primary completion21 Jul 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Cheetah Medical Inc.
- Responsible party
- Principal investigator, Andrew Stasic, Indiana University
- Investigators
- Andrew Stasic, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813915
- Sponsor's protocol ID
- 1508764960
- Acronym
- NICOM
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of a Non-Invasive Cardiac Output in Young Adults
- ClinicalTrials.gov ID
- NCT02813915
- Acronym / sponsor ID
- NICOM / 1508764960
- Conditions
- Fluid Overload, Hypovolemia
- Keywords
- cardiac monitoring, Cheetah Medical, passive leg raises
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Cheetah Medical Inc.
- Study start
- 17 Jul 2016
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 27 Jun 2016 (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 investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with routine monitoring will provide a better assessment of intra-operative status.
Detailed description
This study will involve measurements of cardiac output, stroke volume, and fluid responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before and after anesthesia induction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Cheetah medical NICOM | – | Device: NICOMFor those who consent to the study, the Cheetah NICOM will be used to obtain cardiac output, stroke volume, and fluid responsiveness. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients 18-30 years of age having surgery at Riley or University Hospital
Key inclusion criteria (2 listed)
- 18 -30 years of age
- presenting for surgery at Riley or University Hospital
Key exclusion criteria (5 listed)
- younger than 18
- severely mentally handicapped
- orthopedic cases with leg injuries
- any other contraindications that would prevent or discourage passive leg raises
- if deemed ineligible by an investigator for any other reason.
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 |
|---|---|---|
| NICOMUse of NICOM and PLR to obtain patient fluid status | Device | Use of Cheetah medical NICOM |
Primary outcome
Patient Fluid responsiveness
Time frame: within 30 minutes post-anesthesia induction
If patient is fluid responsive, Stroke Volume Index (SVI) will increase by 10% or greater compared to its baseline
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 3 Oct 2018.
- 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.
Andrew Stasic, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Overload and Hypovolemia, run by Indiana University.
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 5 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient Fluid responsiveness (time frame: within 30 minutes post-anesthesia induction). 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 3 Oct 2018.