Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
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|ClinicalTrials.gov Identifier: NCT03563196|
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment|
|Children Cardiac Surgery Ultrasound||Radiation: Chest Radiograph Diagnostic Test: Lung Ultrasound|
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
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.
|Study Type :||Observational|
|Actual Enrollment :||141 participants|
|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|
All the patients will undergo routine chest radiogram on day 1 after operation
Radiation: Chest Radiograph
Chest radiogram will be obtained on day 1
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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03563196
|Shahid Gangalal National Heart Center|
|Kathmandu, Nepal, 11360|
|Principal Investigator:||smriti M bajracharya, MD||Registrar in Cardiac Anesthesia and ICU|