NCT03563196

Brief Summary

Pulmonary complications are frequent in cardiac surgery, representing an important cause of morbidity, prolongation of hospital stay and need for repeated examinations.Chest X-rays are done routinely and even multiple times to detect such complications.Lung ultrasonography is an alternative test to detect pulmonary complications that can be done easily on bedside. Regularly done Chest X-ray exposes patient to ionizing radiation which can be reduced with ultrasonography. Lung ultrasound is gaining popularity in recent years as a non-invasive,radiation-free tool for the diagnosis of various acute and chronic pulmonary diseases due to its bedside convenience, accuracy, and free of radiation.There is increasing evidence to support the use of Lung ultrasound in acute care setting and post-cardiac surgical patients are also considered critically ill. The purpose of this study is to compare diagnostic performance of lung ultrasound in comparison to chest X-ray to detect pulmonary complication after cardiac surgery in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

June 8, 2018

Last Update Submit

June 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulmonary complications; Pleural effusion;lung consolidation,lung collapse,pneumothorax

    The ultrasound image of pleural effusion is measured by depth of echo-free space between the visceral and parietal pleura. The pulmonary ultrasonic signs of lung consolidation included a hypo-echoic area of varying shape and size with irregular margins of heterogeneous echogenicity and also included dynamic air bronchograms. The main features of atelectasis on LUS included lung consolidation and static air bronchograms. The ultrasound findings of pneumothorax included absent lung sliding and B lines and so are the comet tail artifacts from the pleura

    24 hours

Study Arms (2)

Chest Radiograph

All the patients will undergo routine chest radiogram on day 1 after operation

Radiation: Chest Radiograph

Lung Ultrasound

The same patient will undergo ultrasound evaluation of lungs on day 1 after operation

Diagnostic Test: Lung Ultrasound

Interventions

Chest radiogram will be obtained on day 1

Chest Radiograph
Lung UltrasoundDIAGNOSTIC_TEST

Lung ultrasound will be done on day 1

Lung Ultrasound

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients aged less than 14 years scheduled for cardiac surgery

You may qualify if:

  • Pediatric patients aged less than 14 years scheduled for cardiac surgery in Shahid Gangalal National Heart Center

You may not qualify if:

  • guardian's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Gangalal National Heart Center

Kathmandu, 11360, Nepal

Location

Study Officials

  • smriti M bajracharya, MD

    Registrar in Cardiac Anesthesia and ICU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations