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

NCT ID: NCT04131699

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-01-05

Brief Summary

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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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Detailed Description

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Conditions

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Hemodynamics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pediatric thoracoscopic group

record hemodynamic changes and cardiac output at different intrathoracic pressures ( insufflation pressures 4, 5, 6 mmHg)

Cardiotronic ICON continuous non-invasive cardiac output monitor.

Intervention Type DEVICE

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

Interventions

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Cardiotronic ICON continuous non-invasive cardiac output monitor.

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Mohamed Abd el moneim Soaida, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherif M Soaida, A. professor

Role: STUDY_DIRECTOR

faculty of medicine, Cairo university, Egypt

Sara Abd EL Salam, lecturer

Role: STUDY_DIRECTOR

faculty of medicine, Cairo university, Egypt

Maha G Hanna, professor

Role: STUDY_CHAIR

faculty of medicine, Cairo university, Egypt

Locations

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Faculty of medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SMS2019-1

Identifier Type: -

Identifier Source: org_study_id

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