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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamics
• Intervention / Treatment: Device: Cardiotronic ICON continuous non-invasive cardiac output monitor.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

infants and neonates who are a candidate for thoracoscopic surgeries, and suffer no congenital heart disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pediatric thoracoscopic group; 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.; cardiac index, cardiac output & stroke volume measured and recorded with every change in intrathoracic pressure.

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Sherif M Soaida, A. professor, faculty of medicine, Cairo university, Egypt; Study Director: Sara Abd EL Salam, lecturer, faculty of medicine, Cairo university, Egypt; Study Chair: Maha G Hanna, professor, faculty of medicine, Cairo university, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 5, 2020

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pediatric; hemodynamics; cardiac output; cardiometry; thoracoscopic
• Other Study ID Numbers: SMS2019-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes