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

NCT04131699 | Completed FDA Device

• 1 other identifier: SMS2019-1
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics

Keywords

pediatric; thoracoscopic; cardiometry; cardiac output; hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• heart rate

  from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery

• stroke volume

  from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery

• systemic vascular resistance

  from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery

• cardiac output

  from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery

Study Arms (1)

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.

Interventions

Cardiotronic ICON continuous non-invasive cardiac output monitor. DEVICE

cardiac index, cardiac output \& stroke volume measured and recorded with every change in intrathoracic pressure.

pediatric thoracoscopic group

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Parents' or guardians' refusal.
• Left lateral positioning
• Congenital heart diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Location

Study Officials

• 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 DIRECTOR

• Maha G Hanna, professor

  faculty of medicine, Cairo university, Egypt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 5, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

EG (1)