Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children

NCT ID: NCT03563196

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-30

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.

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.

Conditions

Children; Cardiac Surgery; Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chest Radiograph

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

Chest Radiograph

Intervention Type: RADIATION

Chest radiogram will be obtained on day 1

Lung Ultrasound

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

Lung Ultrasound

Intervention Type: DIAGNOSTIC_TEST

Lung ultrasound will be done on day 1

Interventions

Chest Radiograph

Chest radiogram will be obtained on day 1

Intervention Type: RADIATION

Lung Ultrasound

Lung ultrasound will be done on day 1

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• guardian's refusal

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Gangalal National Heart Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

smriti M bajracharya, MD

Role: PRINCIPAL_INVESTIGATOR

Registrar in Cardiac Anesthesia and ICU

Locations

Shahid Gangalal National Heart Center

Kathmandu, , Nepal

Countries

Nepal

Other Identifiers

SGNHC9

Identifier Type: -

Identifier Source: org_study_id