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

NCT06766045 | Completed DMC

• 1 other identifier: DP.04.03/KEP162/EC087/2023
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragmatic Paralysis

Keywords

Diaphragmatic ultrasound; Fluoroscopy; Diaphragmatic paralysis; Congenital heart disease surgery

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)

  through study completion, an average of 2 years

Secondary Outcomes (2)

• 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

Study Arms (1)

Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery

EXPERIMENTAL

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.

Diagnostic Test: Diaphragmatic Ultrasound; Diagnostic Test: Fluoroscopy

Interventions

Diaphragmatic Ultrasound DIAGNOSTIC_TEST

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.

Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery

Fluoroscopy DIAGNOSTIC_TEST

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.

Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Respiratory Paralysis

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Two different clinicians performed fluoroscopy and diaphragmatic ultrasound without knowing the results of the other tests.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician of Pediatric Cardiology and Congenital Heart Disease, Principal Investigator

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

ID (1)