NCT05317897

Brief Summary

Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

March 25, 2022

Last Update Submit

January 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the sensitivity of lung ultrasound scores

    the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation

    immediately at the end of pediatric cardiac operation

Secondary Outcomes (1)

  • correlation between lung ultrasound score and Po2/Fio2 ratio

    immediatly at the end of pediatric cardiac operation until 6 hours post operative until extubatiioon

Interventions

45 pediatric patients who will go elective repair of congenital acyanotic heart diseases will be included and will be examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined.

Also known as: The lung ultrasound score

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients suffering from Acyanotic congenital heart diseases.

You may qualify if:

  • were Age 6 months to 7 years
  • Patients suffering from Acyanotic congenital heart diseases.

You may not qualify if:

  • Age is less than 6 months and more than 7 years,
  • Preoperative mechanical ventilation,
  • Preoperative inotropic support.,
  • Trisomy 21,
  • Patient with cyanotic heart diseases
  • Coagulopathy INR \>1.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kasr Al Ainy Hospital

Cairo, Cairo Governorate, 11562, Egypt

Location

Kasr Alainy hospital

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, ICU and Pain managment

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 8, 2022

Study Start

September 20, 2018

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations