Diaphragmatic ParalysisUSG vs FluoroNCT06766045
Comparison of Ultrasound with Fluoroscopy to Assess Diaphragmatic Paralysis After Congenital Heart Disease Surgery
A study testing Diaphragmatic Ultrasound and Fluoroscopy in people with Diaphragmatic Paralysis, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diaphragmatic Paralysis
- What is being tested?
- Diaphragmatic Ultrasound and Fluoroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2022to 31 Jul 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11420
About this study
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.
Read the 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
- Being tested
- Diaphragmatic Ultrasound, Fluoroscopy
- Keywords
- Diaphragmatic ultrasound, Fluoroscopy, Diaphragmatic paralysis, Congenital heart disease surgery
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic UltrasoundDiagnostic 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.
FluoroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Diaphragmatic Ultrasound; Diagnostic Test: Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
Incidence of Diaphragmatic Paralysis after congenital heart disease surgery
Measured: through study completion, an average of 2 years
Distress Events during Fluoroscopy and Ultrasound test
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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jun 2022
- Primary completion31 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic ParalysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sisca Natalia Siagian, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766045
- Sponsor's protocol ID
- DP.04.03/KEP162/EC087/2023
- Acronym
- USG vs Fluoro
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound with Fluoroscopy to Assess Diaphragmatic Paralysis After Congenital Heart Disease Surgery
- ClinicalTrials.gov ID
- NCT06766045
- Acronym / sponsor ID
- USG vs Fluoro / DP.04.03/KEP162/EC087/2023
- Conditions
- Diaphragmatic Paralysis
- Keywords
- Diaphragmatic ultrasound, Fluoroscopy, Diaphragmatic paralysis, Congenital heart disease surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Jan 2025 (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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery | Experimental | Diagnostic Test: Diaphragmatic Ultrasound, Diagnostic Test: FluoroscopyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Diaphragmatic UltrasoundDiaphragmatic 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 | Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery |
| FluoroscopyFluoroscopy 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. | Diagnostic test | Assessment of Diaphragmatic Paralysis after Congenital Heart Disease Surgery |
Primary outcome
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Time frame: through study completion, an average of 2 years
2 secondary outcomes
Incidence of Diaphragmatic Paralysis after congenital heart disease surgery
Time frame: through study completion, an average of 2 years
Distress Events during Fluoroscopy and Ultrasound test
Time frame: through study completion, an average of 2 years
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 9 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Ultrasound and Fluoroscopy in people with Diaphragmatic Paralysis, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
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 3 inclusion and 3 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 9 Jan 2025. 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 Indonesia. 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?
sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) (time frame: through study completion, an average of 2 years). 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 9 Jan 2025.