Children Receiving General AnesthesiaNCT01499615
A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
An observational study of Children Receiving General Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Read more about this study
- Who is it for?
- Ages 1 hour to 18 years
- Conditions the study is for
- Children Receiving General Anesthesia
- What is being tested?
- cardiac monitor
- Type of treatment
- Medical device
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- 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 1 hour to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: neonates to teenagers
Who may be able to join
- All children presenting to our operating rooms for general anesthesia
Who cannot join
- Cardiac surgery, open chest procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital
Boston, Massachusetts, 02114
About this study
Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices.
Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.
Read the detailed description
All children undergoing both elective and emergent surgery or GI endoscopy evaluation will be candidates for study. Since this is an FDA approved monitor that is approved across all age groups and since this is an additional monitor over those routinely used in the operating room and since it is noninvasive (4 EKG leads) verbal consent documented in the record has been approved by the IRB.
After informed verbal consent, either the research coordinator or a study physician will populate the cardiac output device with the child's age, weight, gender and height. For older children the required 4 EKG electrodes will be applied prior to induction of anesthesia (2 on the left side of the neck and 2 on the left chest at the level of the sternal depression; for neonates and infants one electrode can be applied to the forehead and the other to a thigh if application space is a problem). For children who are not able to be cooperative, as with most of our monitors the electrodes will be placed after induction of general anesthesia. An automated anesthesia record will continuously record heart rate, respiratory rate, oxygen saturation, systolic and diastolic pressures. The monitor will be set to perform these measurements every 1 minute. New software has been written that enables us to interface the cardiac output device with our automated anesthesia record. Thus the data from the cardiac output device will be inserted on the anesthesia record at approximate 1 minute intervals in real time. The data from the anesthesia records will later be downloaded as a unit to Excel spread sheets for later analysis. All demographic data will also be downloaded (age, weight, ASA physical status,surgical procedure) as well as blood loss and blood and fluid administered as well as drugs,significant intraoperative events, and the timing of events as they evolve. All data will be entered on a Partners password protected computer. Initially the patient's medical record number which links us to the electronic anesthesia record will be recorded as this allows us to download the data. Patient names will not be downloaded. Once the data set is completed,analyzed and locked, the medical record number will be removed so that no identifiers will remain. The data will not be shared with any other institution. Only deidentified data will remain on the final data base
- Conditions
- Children Receiving General Anesthesia
- Being tested
- cardiac monitor
- Keywords
- adverse events, adverse cardiovascular events, early warning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac monitorDevice
All children receive the same intervention which is the application of the 4 ekg electrodes
| Study group | Role | What they receive |
|---|---|---|
| children undergoing general anesthesia | The intervention was the application of 4 ekg electrodes so as to non-invasivly measure cardiac output Receives: Device: cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate adverse cardiovascular events in children under anesthesia with the cardiac output device and standard anesthesia monitors
We plan to record all physiologic data from approximately 400 children under anesthesia and correlate adverse cardiovascular events determined by this new cardiac output device with standard anesthesia monitors
Measured: approximately 18 months
Secondary outcomes (1)
determine if this device provides additonal safety for specific subgroups of pediatric patients under anesthesia e.g., those undergoing laparosopic procedures or procedures involving significant blood loss, neonates
determine is some subgroups within the proposed 400 cases derive specific benefit from this additional non-invasive monitor, i.e., an early warning of impaired cardiac output or a correlation with decreased blood pressure with decreased cardiac output. The issue is whether cardiac out updated at approximate 20 second intervals can provide an eralier warning than the standard 3 to 5 minute blood pressures provided by non-invasive blood pressure monitroing which is the standard of care.
Measured: approximatley 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children Receiving General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Cote, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499615
- Sponsor's protocol ID
- 2010-P-002709/1; MGH
- Status last verified
- Apr 2015
- First submitted
- 20 Dec 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
August DA, Sui J, Cote CJ. Unintentional epidural injection of 88 mug.kg(-1) of epinephrine. Paediatr Anaesth. 2014 Nov;24(11):1185-7. doi: 10.1111/pan.12503. Epub 2014 Aug 11.
PubMed 25130947Cote CJ, Sui J, Anderson TA, Bhattacharya ST, Shank ES, Tuason PM, August DA, Zibaitis A, Firth PG, Fuzaylov G, Leeman MR, Mai CL, Roberts JD Jr. Continuous noninvasive cardiac output in children: is this the next generation of operating room monitors? Initial experience in 402 pediatric patients. Paediatr Anaesth. 2015 Feb;25(2):150-9. doi: 10.1111/pan.12441. Epub 2014 Jun 10.
PubMed 24916144
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT01499615
- Acronym / sponsor ID
- 2010-P-002709/1; MGH
- Conditions
- Children Receiving General Anesthesia
- Keywords
- adverse events, adverse cardiovascular events, early warning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Dec 2011 (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.
Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices.
Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.
Detailed description
All children undergoing both elective and emergent surgery or GI endoscopy evaluation will be candidates for study. Since this is an FDA approved monitor that is approved across all age groups and since this is an additional monitor over those routinely used in the operating room and since it is noninvasive (4 EKG leads) verbal consent documented in the record has been approved by the IRB.
After informed verbal consent, either the research coordinator or a study physician will populate the cardiac output device with the child's age, weight, gender and height. For older children the required 4 EKG electrodes will be applied prior to induction of anesthesia (2 on the left side of the neck and 2 on the left chest at the level of the sternal depression; for neonates and infants one electrode can be applied to the forehead and the other to a thigh if application space is a problem). For children who are not able to be cooperative, as with most of our monitors the electrodes will be placed after induction of general anesthesia. An automated anesthesia record will continuously record heart rate, respiratory rate, oxygen saturation, systolic and diastolic pressures. The monitor will be set to perform these measurements every 1 minute. New software has been written that enables us to interface the cardiac output device with our automated anesthesia record. Thus the data from the cardiac output device will be inserted on the anesthesia record at approximate 1 minute intervals in real time. The data from the anesthesia records will later be downloaded as a unit to Excel spread sheets for later analysis. All demographic data will also be downloaded (age, weight, ASA physical status,surgical procedure) as well as blood loss and blood and fluid administered as well as drugs,significant intraoperative events, and the timing of events as they evolve. All data will be entered on a Partners password protected computer. Initially the patient's medical record number which links us to the electronic anesthesia record will be recorded as this allows us to download the data. Patient names will not be downloaded. Once the data set is completed,analyzed and locked, the medical record number will be removed so that no identifiers will remain. The data will not be shared with any other institution. Only deidentified data will remain on the final data base
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children undergoing general anesthesia | – | Device: cardiac monitorThe intervention was the application of 4 ekg electrodes so as to non-invasivly measure cardiac output |
Who may qualify
- Ages
- 1 hour to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- neonates to teenagers
Key inclusion criteria (1 listed)
- All children presenting to our operating rooms for general anesthesia
Key exclusion criteria (1 listed)
- Cardiac surgery, open chest procedures
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 |
|---|---|---|
| cardiac monitorAll children receive the same intervention which is the application of the 4 ekg electrodes | Device | children undergoing general anesthesia |
Primary outcome
Correlate adverse cardiovascular events in children under anesthesia with the cardiac output device and standard anesthesia monitors
Time frame: approximately 18 months
We plan to record all physiologic data from approximately 400 children under anesthesia and correlate adverse cardiovascular events determined by this new cardiac output device with standard anesthesia monitors
1 secondary outcome
determine if this device provides additonal safety for specific subgroups of pediatric patients under anesthesia e.g., those undergoing laparosopic procedures or procedures involving significant blood loss, neonates
Time frame: approximatley 18 months
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 9 Apr 2015.
- Derived from this study: PubMed 25130947August DA, Sui J, Cote CJ. Unintentional epidural injection of 88 mug.kg(-1) of epinephrine. Paediatr Anaesth. 2014 Nov;24(11):1185-7. doi: 10.1111/pan.12503. Epub 2014 Aug 11.
- Derived from this study: PubMed 24916144Cote CJ, Sui J, Anderson TA, Bhattacharya ST, Shank ES, Tuason PM, August DA, Zibaitis A, Firth PG, Fuzaylov G, Leeman MR, Mai CL, Roberts JD Jr. Continuous noninvasive cardiac output in children: is this the next generation of operating room monitors? Initial experience in 402 pediatric patients. Paediatr Anaesth. 2015 Feb;25(2):150-9. doi: 10.1111/pan.12441. Epub 2014 Jun 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Children Receiving General Anesthesia, run by Massachusetts General Hospital 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 1 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 9 Apr 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 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?
Correlate adverse cardiovascular events in children under anesthesia with the cardiac output device and standard anesthesia monitors (time frame: approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499615, which also lists 2 linked publications.
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 9 Apr 2015.