Clinical trial NCT04131699: Electrical Velocimetry (ICON Cardiometry ) Assessment of Hemodynamic Changes During Pediatric Thoracoscopic Surgery
Official title: Electrical Velocimetry (ICON Cardiometry) Assessment of Hemodynamic Changes With Different Inflation Pressures During Pediatric Thoracoscopic Surgery: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics
Keywords: pediatric
thoracoscopic
cardiometry
cardiac output
hemodynamics
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants and neonates who are a candidate for thoracoscopic surgeries, and suffer no congenital heart disease.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change in Cardiac index
timeFrame: 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:
measure: non invasive blood pressure
timeFrame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure and after deflation till end of surgery
measure: heart rate
timeFrame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
measure: stroke volume
timeFrame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
measure: systemic vascular resistance
timeFrame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
measure: cardiac output
timeFrame: from time of induction of anesthesia and every 5 minutes and after every change in intrathoracic pressure till end of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University
Study officials:
affiliation: faculty of medicine, Cairo university, Egypt
name: Sherif M Soaida, A. professor
role: STUDY_DIRECTOR
affiliation: faculty of medicine, Cairo university, Egypt
name: Sara Abd EL Salam, lecturer
role: STUDY_DIRECTOR
affiliation: faculty of medicine, Cairo university, Egypt
name: Maha G Hanna, professor
role: STUDY_CHAIR
References: