Cardiac Output, LowNICOM2NCT03869606
Non-Invasive Cardiac Output Monitor in Children
An observational study of Cardiac Output, Low and Pediatric, run by Indiana University at 1 site in United States.
Trial summary
This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output, Low, Pediatric
- What is being tested?
- NICOM by Cheetah Medical
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Apr 2020
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy 10 to 17 years old
Who may be able to join
- Patients 11 to no older than 17 years of age
Who cannot join
- severed developmental delay,
- orthopedic patients with leg injuries
- injury that would prevent passive leg elevation.
- severe aortic insufficiency,
- severe anatomic abnormalities of the thoracic aorta
- patients with external cardiac pacemakers. close
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: A Trial of a Non-Invasive Cardiac Output Monitor to Determine Fluid Responsiveness in Children
This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive leg raising, predicts changes in stroke volume, cardiac output, and blood pressure during the early stages of anesthesia. A second study will determine if early treatment of the fluid responsiveness will prevent the decline in blood pressure that accompanies general anesthesia. If the NICOM monitor permits accurate prediction in normal patients, future studies of pediatric patients undergoing major surgery would be indicated.
The investigators would like to add 25 additional patients who will have the NICOM assessments performed in the pre operative area - Pre anesthesia. General anesthesia may alter the results of the NICOM assessments. The investigators will use these 25 subjects to serve as a comparison/control group.
Read the detailed description
Eligible patients will be identified from the surgery schedule and will be contacted by a research team member via phone ahead of their surgery date to inform them of the research study. This call will allow the research team member to answer questions and establish the subject's interest in participation. If interested, or not able to be contacted by phone, patient/family will be approached in the pre-operative area or other private hospital setting. He/she and their parent(s) will have ample time to read the consent and ask any questions regarding the study.
If the subject and his/her parent(s) agree to participate, all standard techniques for general anesthesia compatible with the particular surgical procedure will be employed. Clinical decisions concerning the subject's perioperative care will be made by the anesthesiologist of record.
Cardiac output will be measured with the NICOM cardiac output monitor. The NICOM is a non-invasive monitor using bioreactance, a proprietary technique developed by Cheetah Medical that utilizes delay time shifts to measure stroke volume when an alternating current is passed through the thorax. It requires the placement of four surface electrodes (similar to ECG electrodes) above and below the heart on each side of the patient's chest.
This study will measure cardiac output, stroke volume, and fluid responsiveness (increase in stroke volume > 10%) obtained via passive leg elevation immediately after induction of anesthesia. Adult studies have demonstrated that fifty percent of fasted patients are fluid responsive. The investigators seek to determine the incidence on children.
All decisions concerning clinical care of the subject during the perioperative period will made by the anesthesiologist of record in accordance with accepted standard of care.
- The NICOM® electrodes will be applied in proper position in the pre-op area. In pre-op, baseline and passive leg measurements will be recorded using the NICOM®. Electrodes will remain in place and will again be used during the OR NICOM® measurements.
- Standard physiologic monitors will be used: non-invasive blood pressure, ECG, pulse oximeter, capnograph (end-tidal carbon dioxide), BIS (bispectral analsysis/depth of anesthesia).
- Induction of anesthesia to be determined by the anesthesiologist of record. May be either inhalation or intravenous.
- Measurements recorded after application of NICOM electrodes include blood pressure, heart rate, end-tidal carbon dioxide, arterial oxygen saturation, BIS level, stroke volume, cardiac output.
- After measurement of baseline cardiorespiratory parameters, passive leg elevation to 45 degrees will be performed.
- Cardiorespiratory measurements describe in section d will be repeated after passive leg elevation.
- Cardiorespiratory parameters will be measured during the next 60 minutes of anesthesia. This information will be used to determine whether fluid responsive patients require additional intravenous fluids or vasoactive drugs during the course of anesthesia.
The same procedures listed above will be performed Pre-anesthesia in the Pre operative area, while the subject is fully awake.
General anesthesia may alter the results of the NICOM procedures. The investigators will add 25 patients who will be evaluated with the study procedures pre anesthesia as a control/comparison group.
- Conditions
- Cardiac Output, Low, Pediatric
- Being tested
- NICOM by Cheetah Medical
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICOM by Cheetah MedicalDevice
Observational measurement, Cardiac Output, Pre- and Post Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output via NICOM monitor
Stroke volume x Heart Rate = Cardiac Output
Measured: Pre-Induction and fifteen minutes up to thirty 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 posted11 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Stasic, Indiana University
- Investigators
- Andrew F Stasic, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869606
- Sponsor's protocol ID
- 1808715198
- Acronym
- NICOM2
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of a Non-Invasive Cardiac Output Monitor to Determine Fluid Responsiveness in Children
- ClinicalTrials.gov ID
- NCT03869606
- Acronym / sponsor ID
- NICOM2 / 1808715198
- Conditions
- Cardiac Output, Low, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 11 Mar 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.
This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive leg raising, predicts changes in stroke volume, cardiac output, and blood pressure during the early stages of anesthesia. A second study will determine if early treatment of the fluid responsiveness will prevent the decline in blood pressure that accompanies general anesthesia. If the NICOM monitor permits accurate prediction in normal patients, future studies of pediatric patients undergoing major surgery would be indicated.
The investigators would like to add 25 additional patients who will have the NICOM assessments performed in the pre operative area - Pre anesthesia. General anesthesia may alter the results of the NICOM assessments. The investigators will use these 25 subjects to serve as a comparison/control group.
Detailed description
Eligible patients will be identified from the surgery schedule and will be contacted by a research team member via phone ahead of their surgery date to inform them of the research study. This call will allow the research team member to answer questions and establish the subject's interest in participation. If interested, or not able to be contacted by phone, patient/family will be approached in the pre-operative area or other private hospital setting. He/she and their parent(s) will have ample time to read the consent and ask any questions regarding the study.
If the subject and his/her parent(s) agree to participate, all standard techniques for general anesthesia compatible with the particular surgical procedure will be employed. Clinical decisions concerning the subject's perioperative care will be made by the anesthesiologist of record.
Cardiac output will be measured with the NICOM cardiac output monitor. The NICOM is a non-invasive monitor using bioreactance, a proprietary technique developed by Cheetah Medical that utilizes delay time shifts to measure stroke volume when an alternating current is passed through the thorax. It requires the placement of four surface electrodes (similar to ECG electrodes) above and below the heart on each side of the patient's chest.
This study will measure cardiac output, stroke volume, and fluid responsiveness (increase in stroke volume > 10%) obtained via passive leg elevation immediately after induction of anesthesia. Adult studies have demonstrated that fifty percent of fasted patients are fluid responsive. The investigators seek to determine the incidence on children.
All decisions concerning clinical care of the subject during the perioperative period will made by the anesthesiologist of record in accordance with accepted standard of care.
- The NICOM® electrodes will be applied in proper position in the pre-op area. In pre-op, baseline and passive leg measurements will be recorded using the NICOM®. Electrodes will remain in place and will again be used during the OR NICOM® measurements.
- Standard physiologic monitors will be used: non-invasive blood pressure, ECG, pulse oximeter, capnograph (end-tidal carbon dioxide), BIS (bispectral analsysis/depth of anesthesia).
- Induction of anesthesia to be determined by the anesthesiologist of record. May be either inhalation or intravenous.
- Measurements recorded after application of NICOM electrodes include blood pressure, heart rate, end-tidal carbon dioxide, arterial oxygen saturation, BIS level, stroke volume, cardiac output.
- After measurement of baseline cardiorespiratory parameters, passive leg elevation to 45 degrees will be performed.
- Cardiorespiratory measurements describe in section d will be repeated after passive leg elevation.
- Cardiorespiratory parameters will be measured during the next 60 minutes of anesthesia. This information will be used to determine whether fluid responsive patients require additional intravenous fluids or vasoactive drugs during the course of anesthesia.
The same procedures listed above will be performed Pre-anesthesia in the Pre operative area, while the subject is fully awake.
General anesthesia may alter the results of the NICOM procedures. The investigators will add 25 patients who will be evaluated with the study procedures pre anesthesia as a control/comparison group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy 10 to 17 years old
Key inclusion criteria (1 listed)
- Patients 11 to no older than 17 years of age
Key exclusion criteria (6 listed)
- severed developmental delay,
- orthopedic patients with leg injuries
- injury that would prevent passive leg elevation.
- severe aortic insufficiency,
- severe anatomic abnormalities of the thoracic aorta
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 |
|---|---|---|
| NICOM by Cheetah MedicalObservational measurement, Cardiac Output, Pre- and Post Anesthesia | Device | – |
Primary outcome
Cardiac Output via NICOM monitor
Time frame: Pre-Induction and fifteen minutes up to thirty minutes Post-Anesthesia Induction
Stroke volume x Heart Rate = Cardiac Output
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 30 Jul 2020.
- 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 F Stasic, MD principal investigator
Indiana University
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 Cardiac Output, Low and Pediatric, run by Indiana University at 1 site in United States.
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 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: finished, as of the sponsor's last update on 30 Jul 2020. 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 United States. 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?
Cardiac Output via NICOM monitor (time frame: Pre-Induction and fifteen minutes up to thirty 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 30 Jul 2020.