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NCT Number: NCT04131699

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

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.

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Key information

Conditions

Hemodynamics

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiotronic ICON continuous non-invasive cardiac output monitor.

Device

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

Primary outcomes

  1. change in Cardiac index

    Time frame: 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 outcomes

  1. non invasive blood pressure

    Time frame: 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

  2. heart rate

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

    beats per minute

  3. stroke volume

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

    millilitres

  4. systemic vascular resistance

    Time frame: 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

  5. cardiac output

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

    l/min

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 18, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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