Electrical Velocimetry (ICON Cardiometry ) Assessment of Hemodynamic Changes During Pediatric Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the surgical approach and the installation of carbon dioxide into the thoracic cavity can lead to alterations of normal acid-base status. Finally, surgical procedures in the chest, surgical traction or insufflation pressures impairs venous return and/or cardiac function, especially in neonates and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical, Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure (insufflation pressures 4,5 & 6 mmHg) during thoracoscopic surgeries in neonates and infants on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.

Official Title
-----------------
Electrical Velocimetry (ICON Cardiometry) Assessment of Hemodynamic Changes With Different Inflation Pressures During Pediatric Thoracoscopic Surgery: A Pilot Study

Conditions
-----------------
Hemodynamics

Intervention / Treatment
-----------------
* Device: Cardiotronic ICON continuous non-invasive cardiac output monitor.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II. Age neonates and infants Children undergoing thoracoscopic surgery surgeries. Exclusion Criteria: Parents' or guardians' refusal. Left lateral positioning Congenital heart diseases.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pediatric thoracoscopic group<br>record hemodynamic changes and cardiac output at different intrathoracic pressures ( insufflation pressures 4, 5, 6 mmHg) | Device: Cardiotronic ICON continuous non-invasive cardiac output monitor.<br>* cardiac index, cardiac output & stroke volume measured and recorded with every change in intrathoracic pressure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Cardiac index | L/min/m2 | measured before inflation, 1 minute after inflation of the thoracic cavity at 4 mm Hg, 5 mm Hg and 6 mm Hg and after deflation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non invasive blood pressure | mmHg | from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure and after deflation till end of surgery | 
| heart rate | beats per minute | from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery | 
| stroke volume | millilitres | from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery | 
| systemic vascular resistance | dynes/seconds/cm-5 | from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery | 
| cardiac output | l/min | from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, thoracoscopic, cardiometry, cardiac output, hemodynamics