ChildrenNCT03563196
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
An observational study of Children and Cardiac Surgery, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Children, Cardiac Surgery, Ultrasound
- What is being tested?
- Chest Radiograph and Lung Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteNepal
- Study dates
- Sep 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged less than 14 years scheduled for cardiac surgery
Who may be able to join
- Pediatric patients aged less than 14 years scheduled for cardiac surgery in Shahid Gangalal National Heart Center
Who cannot join
- guardian's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Lung Ultrasound To Chest Radiography For Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
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.
Read the 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
- Being tested
- Chest Radiograph, Lung Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest RadiographRadiation
Chest radiogram will be obtained on day 1
Lung UltrasoundDiagnostic test
Lung ultrasound will be done on day 1
| Study group | Role | What they receive |
|---|---|---|
| Chest Radiograph | All the patients will undergo routine chest radiogram on day 1 after operation Receives: Radiation: Chest Radiograph | |
| Lung Ultrasound | The same patient will undergo ultrasound evaluation of lungs on day 1 after operation Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Gangalal National Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- smriti M bajracharya, MD, Principal investigator, Registrar in Cardiac Anesthesia and ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563196
- Sponsor's protocol ID
- SGNHC9
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Lung Ultrasound To Chest Radiography For Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
- ClinicalTrials.gov ID
- NCT03563196
- Acronym / sponsor ID
- SGNHC9
- Conditions
- Children, Cardiac Surgery, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Shahid Gangalal National Heart CentreUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Radiograph | – | Radiation: Chest RadiographAll the patients will undergo routine chest radiogram on day 1 after operation |
| Lung Ultrasound | – | Diagnostic Test: Lung UltrasoundThe same patient will undergo ultrasound evaluation of lungs on day 1 after operation |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged less than 14 years scheduled for cardiac surgery
Key inclusion criteria (1 listed)
- Pediatric patients aged less than 14 years scheduled for cardiac surgery in Shahid Gangalal National Heart Center
Key exclusion criteria (1 listed)
- guardian's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest RadiographChest radiogram will be obtained on day 1 | Radiation | Chest Radiograph |
| Lung UltrasoundLung ultrasound will be done on day 1 | Diagnostic test | Lung Ultrasound |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
smriti M bajracharya, MD principal investigator
Registrar in Cardiac Anesthesia and ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Cardiac Surgery, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary complications; Pleural effusion;lung consolidation,lung collapse,pneumothorax (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.