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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04131699
Other study ID # SMS2019-1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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