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

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131699
• Other study ID #: SMS2019-1
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: January 5, 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 5, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Device:
• Cardiotronic ICON continuous non-invasive cardiac output monitor.
cardiac index, cardiac output & stroke volume measured and recorded with every change in intrathoracic pressure.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	stroke volume	millilitres	from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
Secondary	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
Secondary	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