The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound Score

NCT04311918 | Unknown

• 1 other identifier: MD-20-2020
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic catheterizations substituted many traditional surgical procedures with the advance of transcatheter techniques. Pediatric patients are more liable to fluid overload due to their smaller weights compared to adults and the risk increases in pediatrics with congenital heart diseases due to lower tolerability and reserve capacity and some of them may already have a degree of heart failure. Fluid overload increases the incidence of morbidity and mortality in such patients. The aim of our study is to observe the amount of fluids needed for flushing during pediatric cardiac catheterization (in ml/kg) and asses its effect on total lung water and PaO2/FiO2, aiming to develop a useful protocol for the amount of fluids used.

Conditions

Congenital Heart Disease

Keywords

congenital - cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• Change between lung ultrasound score before and after fluids flushed

  heparinized fluids are flushed throughout catheterization through venous and arterial sheathes , ultrasound score will be measured before and after the flushing

  at the start of the procedure of cardiac catherization and immediately after the end of the procedure

Secondary Outcomes (2)

• . Change between PaO2/FiO2 ratio

  immediately before and immediately after the procedure.

• Correlation between lung score and PaO2/FiO2 ratio

  immediately before and immediately after the procedure.

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children from 1 month to 6 years undergoing cardiac catheterization procedures.. This study will be conducted at Abo El Reesh Paediatric Hospital, Faculty of Medicine

You may qualify if:

• Pediatric patients undergoing diagnostic cardiac catheterization procedures.

You may not qualify if:

• Age \<1 month and \>6 years.
• Preoperative mechanical ventilation.
• Heart failure
• Patients with oligemic lung diseases.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Pediatric Hospitals

Giza, الجيزة, 12555, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 17, 2020
• Study Start: March 1, 2020
• Primary Completion: October 15, 2020
• Study Completion: March 15, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

EG (1)