Cardiac Output in Children During Anesthesia | NCT04044157

Studies
Cardiac Output in Children During Anesthesia

NCT04044157

Sponsor

Laszlo Vutskits

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Perioperative Period
Cardiac Output
Pediatric Anesthesia
Arterial Hypotension

Interventions

non-invasive measurement of cardiac output

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2019Actual

Primary Completion Date

Mar 17, 2020Actual

Completion Date

Mar 19, 2020Actual

First Submitted Date

Jul 31, 2019

First Submission Date that Met QC Criteria

Jul 31, 2019

First Posted Date

Aug 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2020

Last Update Posted Date

Dec 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laszlo Vutskits, Head of Pediatric Anesthesia, University Hospital, GenevaSponsor-Investigator

Lead Sponsor

Laszlo VutskitsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive measurement of cardiac output	Other	cardiac output will be non-invasivaly measured by means of electrical cardiometry		no other intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac output	Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry	Measurements start before the induction of anesthesia and ends at emergence from anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Association between cardiac output and blood pressure during anesthesia	Describe how cardiac output and blood pressure are associated in infants during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Association between cardiac output and cerebral NIRS during anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Months

Standard Ages

Child

Study Population

Children under 18 months undergoing elective surgery lasting more than 30 minutes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laszlo Vutskits, MD PhD	University Hosptials of Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Geneva		Geneva		1205	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided