Perioperative PeriodCOCNCT04044157
Cardiac Output in Children During Anesthesia
An observational study of Perioperative Period and Cardiac Output, run by Laszlo Vutskits at 1 site in Switzerland.
Trial summary
This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry. Read more about this study
- Who is it for?
- Ages Up to 17 months
- Conditions the study is for
- Perioperative Period, Cardiac Output, Pediatric Anesthesia
- What is being tested?
- non-invasive measurement of cardiac output
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2019to 19 Mar 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 Up to 17 months
- All sexes
- Child
Study population: Children under 18 months undergoing elective surgery lasting more than 30 minutes.
Who may be able to join
- age 0 to 17 months included
- undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time)
- parental/guardian permission (informed consent) obtained
- ASA 1-3 status
Who cannot join
- structural/anatomical anomaly or other circumstances (e.g. patient positioning) making it difficult to apply the sensors to the body
- history of congenital heart diseases
- known allergy to electrodes' glue
- emergency surgery
- prematurity (born before 37 week PMA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study
This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.
Read the detailed description
Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.
Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and pediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the temporal patterns of cardiac output changes in otherwise healthy young children undergoing routine surgical procedures have not been systematically reported. This information is important since it will increase our understanding of hemodynamic changes in small children during anesthesia/surgery and would ultimately lead to a better anesthesia care in this patient population.
The primary objective of this pilot exploratory observational study is to describe temporal patterns of cardiac output in young children ( under18 months of age) during the perioperative period. The secondary objectives are to describe how changes in cardiac output are associated with (i) non-invasively-measured systemic arterial blood pressure; (ii) near-infrared spectroscopy; (iii) other anesthesia factors (arterial oxygen saturation, concentration of anesthesia agents, CO2 levels).
- Being tested
- non-invasive measurement of cardiac output
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive measurement of cardiac outputOther
Also called no other intervention
cardiac output will be non-invasivaly measured by means of electrical cardiometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry
Measured: Measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary outcomes (3)
Association between cardiac output and blood pressure during anesthesia
Describe how cardiac output and blood pressure are associated in infants during anesthesia
Measured: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Association between cardiac output and cerebral NIRS during anesthesia
Describe how cardiac output and cerebral NIRS are associated in infants during anesthesia
Measured: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia
Describe how cardiac output and other anesthesia factors are associated in infants during anesthesia
Measured: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start23 Sep 2019
- Primary completion17 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PeriodStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laszlo Vutskits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laszlo Vutskits, University Hospital, Geneva
- Investigators
- Laszlo Vutskits, MD PhD, Principal investigator, University Hosptials of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044157
- Sponsor's protocol ID
- BASEC 2019-00884
- Acronym
- COC
- Status last verified
- Dec 2020
- First submitted
- 31 Jul 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study
- ClinicalTrials.gov ID
- NCT04044157
- Acronym / sponsor ID
- COC / BASEC 2019-00884
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Laszlo VutskitsUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 5 Aug 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 investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.
Detailed description
Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.
Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and pediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the temporal patterns of cardiac output changes in otherwise healthy young children undergoing routine surgical procedures have not been systematically reported. This information is important since it will increase our understanding of hemodynamic changes in small children during anesthesia/surgery and would ultimately lead to a better anesthesia care in this patient population.
The primary objective of this pilot exploratory observational study is to describe temporal patterns of cardiac output in young children ( under18 months of age) during the perioperative period. The secondary objectives are to describe how changes in cardiac output are associated with (i) non-invasively-measured systemic arterial blood pressure; (ii) near-infrared spectroscopy; (iii) other anesthesia factors (arterial oxygen saturation, concentration of anesthesia agents, CO2 levels).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 months
- Sex
- All
- Age groups
- Child
- Study population
- Children under 18 months undergoing elective surgery lasting more than 30 minutes.
Key inclusion criteria (4 listed)
- age 0 to 17 months included
- undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time)
- parental/guardian permission (informed consent) obtained
- ASA 1-3 status
Key exclusion criteria (5 listed)
- structural/anatomical anomaly or other circumstances (e.g. patient positioning) making it difficult to apply the sensors to the body
- history of congenital heart diseases
- known allergy to electrodes' glue
- emergency surgery
- prematurity (born before 37 week PMA)
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 |
|---|---|---|
| non-invasive measurement of cardiac outputAlso: no other interventioncardiac output will be non-invasivaly measured by means of electrical cardiometry | Other | – |
Primary outcome
Cardiac output
Time frame: Measurements start before the induction of anesthesia and ends at emergence from anesthesia
Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry
3 secondary outcomes
Association between cardiac output and blood pressure during anesthesia
Time frame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Association between cardiac output and cerebral NIRS during anesthesia
Time frame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia
Time frame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
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 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Laszlo Vutskits, MD PhD principal investigator
University Hosptials of Geneva
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 Perioperative Period and Cardiac Output, run by Laszlo Vutskits at 1 site in Switzerland.
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 4 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 21 Dec 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 Switzerland. 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 (time frame: Measurements start before the induction of anesthesia and ends at emergence from anesthesia). 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 Dec 2020.