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

Completed

• Conditions: Hemodynamics
• Interventions: Device: Cardiotronic ICON continuous non-invasive cardiac output monitor.

• Registration Number: NCT04131699
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-11-01
• Primary Completion: 2019-12-31
• Status Verified: 2020-01
• Study Completion: 2020-01-05
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. ASA physical status I-II.
2. Age neonates and infants
3. Children undergoing thoracoscopic surgery surgeries.

Exclusion Criteria

1. Parents' or guardians' refusal.
2. Left lateral positioning
3. Congenital heart diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pediatric thoracoscopic group	Cardiotronic ICON continuous non-invasive cardiac output monitor.	record hemodynamic changes and cardiac output at different intrathoracic pressures ( insufflation pressures 4, 5, 6 mmHg)

Primary Outcome Measures

Name	Time	Method
change in Cardiac index	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	L/min/m2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of medicine, Cairo University; 🇪🇬 Cairo, Egypt