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Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03563196
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
Shahid Gangalal National Heart Centre

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.

Condition or disease Intervention/treatment
Children Cardiac Surgery Ultrasound Radiation: Chest Radiograph Diagnostic Test: Lung Ultrasound

Detailed Description:

Study type: Comparative Study design: Non-randomized,all patients will undergo both ultrasound and chest Xray.

Model:cohort time perspective: prospective Sampling method: non-probability sample Study population: Children less than 14 years Sample size: 54 Place of Study-Shahid Gangalal national Heart Center, Surgical intensive care unit Duration of study: six months Hypothesis: Chest X-ray and Lung ultrasound are equally effective in detecting postoperative pulmonary complications

Inclusion criteria:

Patients after undergoing cardiac surgery who are age below 14 years on post-operative Day 1.

Exclusion criteria Patient's /Guardians' refusal IMAGING PROTOCOL AND TECHNIQUE Following institutional review board approval, a written informed consent will be obtained from all the patients meeting the inclusion criteria before undergoing surgery on pre-operative visit before enrollment in the study.

Lung Ultrasound will be done on the first post-operative day of cardiac surgery and will be compared to Chest X-ray done on the same day for any pulmonary complications . Lung ultrasound examination will be performed by radiologist to detect pleural effusion, consolidation, pulmonary atelectasis, pneumothorax and pulmonary congestion, using Siemens AUCUSON Freestyle Diagnostic Ultrasound System L13-5 linear probe. The transthoracic Lung ultrasound approach will be done in supine and both lateral decubitus positions of the anterior lung area (between the sternum and the anterior axillary line), lateral lung area (between the anterior and posterior axillary lines), and posterior lung area (between the posterior axillary line and the spine) in caudo-cranial direction. Longitudinal, transverse and oblique scans will be included. A routine plain chest radiograph will be obtained in each patient on the same day before performing ultrasound which will be evaluated by an intensivist to detect pleural effusion, consolidation, pulmonary atelectasis, pneumothorax. Both the radiologist and intensivist will be blinded to each other's findings. Comparison of the findings will be done at the end of study.

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Of Lung Ultrasound To Chest Radiography For Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Actual Study Start Date : September 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Chest Radiograph
All the patients will undergo routine chest radiogram on day 1 after operation
Radiation: Chest Radiograph
Chest radiogram will be obtained on day 1

Lung Ultrasound
The same patient will undergo ultrasound evaluation of lungs on day 1 after operation
Diagnostic Test: Lung Ultrasound
Lung ultrasound will be done on day 1

Primary Outcome Measures :
  1. Pulmonary complications; Pleural effusion;lung consolidation,lung collapse,pneumothorax [ Time Frame: 24 hours ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients aged less than 14 years scheduled for cardiac surgery

Inclusion Criteria:

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

Exclusion Criteria:

  • guardian's refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03563196

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Shahid Gangalal National Heart Center
Kathmandu, Nepal, 11360
Sponsors and Collaborators
Shahid Gangalal National Heart Centre
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Principal Investigator: smriti M bajracharya, MD Registrar in Cardiac Anesthesia and ICU

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Responsible Party: Shahid Gangalal National Heart Centre Identifier: NCT03563196     History of Changes
Other Study ID Numbers: SGNHC9
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No