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

Not Applicable

Completed

• Conditions: Diaphragmatic Paralysis

• Registration Number: NCT06766045
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-07-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)	through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
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	During both procedures, patients' conditions were documented to monitor any distress event. Distress event was positive if the patients' conditions met one of these criteria: (1) increased heart rate \> 90th percentile based on age according to Pediatric Advanced Life Support (PALS), (2) decreased heart rate \< -90th percentile based on age according to PALS, (3) cardiac arrest, (4) life-threatening arrhythmia, (5) decreased peripheral oxygen saturation \>20% from baseline/preprocedure, (6) increased body temperature \>38oC, and (7) partial or generalized seizure.

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, DKI Jakarta, Indonesia