Carotid Artery Blood Flow, Blood Pressure, and Cardiac Output During Anesthesia in Children Aged 0-5 Years

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-5
SponsorKarolinska Institutet

About this trial

Blood pressure is routinely monitored during anesthesia in children, but blood pressure alone may not accurately reflect blood flow to vital organs. This is particularly important in infants and young children, in whom normal cardiovascular values vary with age.

The CARFLOW study is a prospective observational study of 100 children aged 0-5 years undergoing anesthesia and surgery. The purpose is to investigate how blood flow in the common carotid artery, measured non-invasively using Doppler ultrasound, relates to blood pressure and cardiac output during anesthesia.

Carotid artery blood flow will be measured before and during anesthesia and compared with blood pressure recorded as part of routine monitoring. In children who are intubated, cardiac output will also be measured non-invasively using a capnodynamic method.

The main questions are whether changes in blood pressure are associated with changes in carotid artery blood flow, how carotid artery blood flow relates to cardiac output, and whether reference values for carotid artery blood flow during anesthesia can be established for young children.

All clinical decisions and treatment will follow routine clinical practice. Measurements performed as part of the study will not be used to guide treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 0-5 years

Scheduled for elective surgery under general anesthesia at the Pediatric Operating Department, Karolinska University Hospital

Written informed consent provided by a parent or legal guardian

Disqualifiers

Emergency surgery

American Society of Anesthesiologists (ASA) physical status ≥3

Significant comorbidity

Expected complicated anesthesia or surgical procedure

Trial population

The study population will be recruited from children undergoing elective surgical procedures requiring general anesthesia at the Pediatric Operating Department, Karolinska University Hospital, Solna, Sweden. Participants will be identified among patients scheduled for routine clinical care at the study site.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Children Undergoing General Anesthesia

Trial outcomes

Primary outcomes

1

Common Carotid Artery Blood Flow in Relation to Blood Pressure During Anesthesia

Common carotid artery blood flow will be measured in the right common carotid artery using Doppler ultrasound and analyzed in relation to simultaneously recorded blood pressure. Measurements will include observations before and after induction of anesthesia and repeated paired measurements during anesthesia, including measurements obtained when blood pressure falls below the predefined clinical threshold and after clinically indicated treatment to increase blood pressure.

Time frame
During anesthesia, up to 2 hours
2

Relationship between common carotid artery blood flow and blood pressure during anesthesia.

Common carotid artery blood flow will be measured non-invasively in the common carotid artery using Doppler ultrasound and compared with simultaneously recorded blood pressure. Measurements will be obtained before induction of anesthesia, after induction and securing of the airway, at 15-minute intervals during anesthesia, when blood pressure falls below the predefined clinical threshold, and approximately 3 minutes after clinically indicated treatment to increase blood pressure. The analysis will assess the relationship between carotid artery blood flow and blood pressure and whether low blood pressure is consistently associated with reduced carotid artery blood flow.

Time frame
From before induction of anesthesia until the end of anesthesia, up to 2 hours

Secondary outcomes

1

Common Carotid Artery Blood Flow in Relation to Cardiac Output During Anesthesia

In children who are tracheally intubated, cardiac output will be measured non-invasively using the capnodynamic method. Common carotid artery blood flow measured using Doppler ultrasound will be analyzed in relation to simultaneously measured cardiac output.

Time frame
During anesthesia, up to 2 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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