Comparison of Ultrasound with Fluoroscopy to Assess Diaphragmatic Paralysis After Congenital Heart Disease Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Study Overview
Brief Summary
Diaphragmatic paralysis after congenital heart disease (CHD) surgery can increase patient mortality and morbidity, especially for the vulnerable pediatric patient. Establishing a diagnosis of this disorder is key for making follow-up decisions such as diaphragm plication. Fluoroscopy as the gold standard has limitations in assessing diaphragmatic paralysis after CHD surgery Objective: To compare diaphragmatic ultrasound with fluoroscopy as the diagnostic method for diaphragmatic paralysis after CHD surgery.
Detailed Description
Diaphragmatic paralysis is a common cause of delayed recovery and morbidity after cardiovascular surgery which accounts for 64% of all causes of phrenic nerve lesions. Similarly, congenital heart disease surgery is commonly associated with phrenic nerve injury resulting in diaphragmatic dysfunction in pediatric patients with an incidence of 0.3-5.4%. The phrenic nerve can be injured through various mechanisms such as hypothermia due to ice cold slush for myocardial protection, dissection near the pedicle area of the internal thoracic artery, dissection or conduction of heat along the path or area of the phrenic nerve, etc. Diaphragmatic paralysis is usually transient and not clinically significant in adult, but it is a serious and life-threatening complication that causes respiratory distress in pediatric patient.
Various diagnostic techniques can be used to assess diaphragmatic paralysis such as chest X-ray, fluoroscopy, computed tomography (CT), dynamic magnetic resonance imaging (MRI), and electromyography. The fluoroscopy test has been the method of choice to diagnose diaphragmatic paralysis as it is relatively easy to perform. Earlier studies diagnosed unilateral diaphragmatic paralysis by evaluating the dynamic motion of the diaphragm using fluoroscopy. However, there are several disadvantages of fluoroscopy tests such as requiring cooperation from the patient, requiring the patient in an upright position, the difficulty in transporting patients from the ICU to the fluoroscopy room or cath lab, especially in unstable patients who may deteriorate, the cumulative burden of exposure to radiation, and the relatively high costs.
Diaphragmatic ultrasound (two-dimensional combined with M-mode) is a fast, simple, cheap, accurate, non-radiation noninvasive study that is widely available and increasingly used both in clinical setting and researches. Bedside ultrasound can be used for immobilized or intensive care patients. The simpler procedure helps assessing diaphragmatic paralysis in pediatric patients. The combination of B-mode and M-mode in ultrasound can quantitatively assess the distance and amplitude of diaphragm motion on both sides so that it may provide objective quantification. Therefore, this study was conducted to compare diaphragmatic ultrasound with fluoroscopy as the diagnostic method of diaphragmatic paralysis after congenital heart disease surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Two different clinicians performed fluoroscopy and diaphragmatic ultrasound without knowing the results of the other tests.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who had congenital heart disease (CHD) surgery in National Cardiovascular Center Harapan Kita (NCCHK)
- •Suspected of diaphragmatic paralysis based on clinical symptoms and X-ray examination.
- •The conditions indicating diaphragmatic paralysis in patients after CHD surgery were mechanical ventilation dependence, increased respiratory effort and reduced peripheral oxygen saturation when breathing spontaneously, recurrent respiratory tract infection, and chest X-ray showing right hemidiaphragm >2 cm higher than left diaphragm or left diaphragm at the same level or higher than right diaphragm
Exclusion Criteria
- •Patients who could not achieve oxygen saturation targets with the help of minimal pressure support such as continuous positive airway pressure (CPAP) or pressure support intermittent mandatory ventilation (P SIMV)
- •Refusal from the patient/family to be included in the study
- •Past medical history of diaphragmatic disorder.
Arms & Interventions
Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery
The included patients who were suspected of diaphragmatic paralysis based on clinical symptoms and X-ray examination would first undergo fluoroscopy test, continued by ultrasound examination less than 24 hours apart. The patients were weaned off from mechanical ventilation (spontaneous breathing) and switched to minimal mechanical ventilation support (CPAP/P SIMV) before the examination. The examination and data collection were performed by two different operators: diaphragmatic ultrasound by pediatric intencivist and fluoroscopy test by pediatric cardiologist.
Intervention: Diaphragmatic Ultrasound (Diagnostic Test)
Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery
The included patients who were suspected of diaphragmatic paralysis based on clinical symptoms and X-ray examination would first undergo fluoroscopy test, continued by ultrasound examination less than 24 hours apart. The patients were weaned off from mechanical ventilation (spontaneous breathing) and switched to minimal mechanical ventilation support (CPAP/P SIMV) before the examination. The examination and data collection were performed by two different operators: diaphragmatic ultrasound by pediatric intencivist and fluoroscopy test by pediatric cardiologist.
Intervention: Fluoroscopy (Diagnostic Test)
Outcomes
Primary Outcomes
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Time Frame: through study completion, an average of 2 years
Secondary Outcomes
- Incidence of Diaphragmatic Paralysis after congenital heart disease surgery(through study completion, an average of 2 years)
- Distress Events during Fluoroscopy and Ultrasound test(through study completion, an average of 2 years)
Investigators
Sisca Natalia Siagian
Physician of Pediatric Cardiology and Congenital Heart Disease, Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia