NCT06766045

Comparison of Ultrasound with Fluoroscopy to Assess Diaphragmatic Paralysis After Congenital Heart Disease Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diaphragmatic Paralysis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diaphragmatic Ultrasound	Diaphragmatic ultrasound was performed bedside in the ICU with supine position. Diaphragmatic thickness was measured by placing the ultrasound on 8th-10th intercostal space between anterior and mid-axillary line with marker at 12 o'clock. B-mode ultrasound was used to measure the distance between thoracic and abdominal diaphragm which resulted in the diaphragmatic thickness at inspiration (DTi) and diaphragmatic thickness at expiration (DTe). The ultrasound was then placed on the subcostal area between anterior and mid-axillary line with marker at 12 o'clock to observe the diaphragmatic motion on each side. Measurement of diaphragmatic excursion as well as recording and evaluation of diaphragmatic sliding and motion were performed during both inspiration and expiration using M-mode.
DIAGNOSTIC_TEST	Fluoroscopy	Fluoroscopy test was conducted in cathlab with supine position and anteroposterior (AP) projection for at least 5 breathing cycles. The fluoroscopy recording was then expertised and interpreted by the pediatric cardiologist in charge.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-31
• Completion: 2024-07-31
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: Indonesia