POCUS Assessment During Ambulatory PAH ClinicPOCUSPAHNCT05332847
Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic
A study testing POC-US in people with POCUS Assessment During Ambulatory PAH Clinic, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Background: Changes occurring in the pulmonary vascularity imparts changes to the right heart in patients with pulmonary arterial hypertension (PAH). Importantly changes in RV function correlates with severity of disease and patient outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- POCUS Assessment During Ambulatory PAH Clinic
- What is being tested?
- POC-US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jan 2018to 30 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with PAH defined by the Updated clinical classification of pulmonary hypertension criteria.
- Age ≥ 18
- Baseline values from right-heart catheterization results for the definite diagnosis of PH: Hemodynamic inclusion: resting mPAP > 25mmHg, PCWP < 15mmHg, and PVR > 3 Woods Units.
Who cannot join
- Inability to give informed consent.
- Clear evidence of Group 2-5 PH. We will also exclude patients with PAH on the basis of congenital heart disease, liver cirrhosis or suspected pulmonary veno-occlusive disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic Changes Patients' Management- A Randomized Controlled Pilot Study
Background: Changes occurring in the pulmonary vascularity imparts changes to the right heart in patients with pulmonary arterial hypertension (PAH). Importantly changes in RV function correlates with severity of disease and patient outcome. This affords and opportunity to assess patients longitudinally through point of care ultrasonography. Investigators objective was to measure the percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic, and to compared management change rate between patients with PAH who underwent point of care ultrasonography (POCUS) assessment in addition to the routine evaluation, and a control group to which the investigators did not add a test with POCUS in addition to the routine evaluation in the clinic.
Methods: Consecutive patients from the PAH clinic in two medical centers were randomized to the POCUS assessment group and the non-POCUS group. The POCUS group received lung, heart, and vascular ultrasound assessments. All other assessments were the same between both groups. Management changes were documented during each of the patients' visits over a three-month interval.
Read the detailed description
The investigators included patients if they were diagnosed with group 1 PH (PAH), as defined by the updated clinical classification of PH and provided informed consent. Patients were excluded if diagnosed with PH group 2-5, had congenital heart disease, liver cirrhosis, or suspected pulmonary venous-occlusive disease. On enrollment, randomization of the patient was done 1:1 (using ClinStat) to either the POCUS assessment group or control group. Both groups underwent the same clinical assessment according to PH clinic protocol and by the same treating pulmonologist (A.A.). Every patient was scheduled to a follow up meeting every three months as part of the usual PAH clinic routine. The study protocol was approved by each participating center's research ethics board (BRZ 0106-18, SOR0327-16).
At each clinic visit evaluations for both groups were standardized. Each visit included a history, physical and laboratory evaluation, BNP level, 6-minute walk test, and quality of life as assessed using emPHasis 10.
Prior to the decision regarding patient management, the pulmonologist at the PAH clinic knew the test results including a POCUS test done in the intervention group. A change in the patient's management in the clinic is represented by the clinician's recommendation for a change in medication, sending the patient for a lung transplant, hospitalization, or other diagnostic or therapeutic procedure documented
Patients in the intervention group underwent a bedside-focused sonographic assessment of the heart, lungs, abdomen, and IVC in every clinic visit during the period of study. The exam was conducted either at the beginning or after the regular patient assessment. The Investigators used 2-dimensional views, the parasternal long and short axis, subcostal long and IVC, apical 5, 4, 2 chamber view. As this exam was POCUS centered and not a formal cardiac study. When pathologies were identified, relevant measurements were made, and the patient was referred for a formal echo. For example, when a calcified aortic valve was detected, and aortic stenosis was suspected a continuous pulse wave Doppler for maximal velocity measurement was conducted. Standard measurements were for left ventricle wall thickness, size of ventricles and atria, IVC size and collapsibility index, RVSP when TR was identified, TAPSE, and size of pericardial effusion when found. Lung ultrasound was focused on the detection of pulmonary congestion (screening and counting B-lines on both lungs, midclavicular line and midaxillary line), pleural effusion, lung atelectasis, lung consolidations (mid and posterior axillary lines), and sliding of pleura (midclavicular line). The investigators performed Doppler for DVT only within the right clinical context. All POCUS exams were documented in a standardized form. Findings were reported in real-time to the treating pulmonologist and were documented in the follow-up notes.
- Being tested
- POC-US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC-USDevice
Also called clinic visit evaluations
Point Of Care Ultrasonography (POCUS) is a rapidly evolving bedside modality in which ultrasonography is utilized as a part of the bedside physical examination and the patients' clinical assessment
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | The intervention group underwent clinical evaluation and a bedside-focused sonographic assessment Receives: Device: POC-US |
| control group. | No intervention | The control group underwent clinical evaluation without POC-US |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic
Measured: 9 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start14 Jan 2018
- Primary completion11 Mar 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for POCUS Assessment During Ambulatory PAH ClinicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avital Keren Abriel MD, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332847
- Sponsor's protocol ID
- 032716SOR
- Acronym
- POCUSPAH
- Status last verified
- Apr 2022
- First submitted
- 13 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Avriel A, Bar Lavie Shay A, Hershko Klement A, Taylor J, Shamia D, Tsaban G, Abu-Shakra M, Granton J, Fuchs L. Point-of-Care Ultrasonography in a Pulmonary Hypertension Clinic: A Randomized Pilot Study. J Clin Med. 2023 Feb 22;12(5):1752. doi: 10.3390/jcm12051752.
PubMed 36902536
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic Changes Patients' Management- A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05332847
- Acronym / sponsor ID
- POCUSPAH / 032716SOR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Apr 2022 (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.
Background: Changes occurring in the pulmonary vascularity imparts changes to the right heart in patients with pulmonary arterial hypertension (PAH). Importantly changes in RV function correlates with severity of disease and patient outcome. This affords and opportunity to assess patients longitudinally through point of care ultrasonography. Investigators objective was to measure the percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic, and to compared management change rate between patients with PAH who underwent point of care ultrasonography (POCUS) assessment in addition to the routine evaluation, and a control group to which the investigators did not add a test with POCUS in addition to the routine evaluation in the clinic.
Methods: Consecutive patients from the PAH clinic in two medical centers were randomized to the POCUS assessment group and the non-POCUS group. The POCUS group received lung, heart, and vascular ultrasound assessments. All other assessments were the same between both groups. Management changes were documented during each of the patients' visits over a three-month interval.
Detailed description
The investigators included patients if they were diagnosed with group 1 PH (PAH), as defined by the updated clinical classification of PH and provided informed consent. Patients were excluded if diagnosed with PH group 2-5, had congenital heart disease, liver cirrhosis, or suspected pulmonary venous-occlusive disease. On enrollment, randomization of the patient was done 1:1 (using ClinStat) to either the POCUS assessment group or control group. Both groups underwent the same clinical assessment according to PH clinic protocol and by the same treating pulmonologist (A.A.). Every patient was scheduled to a follow up meeting every three months as part of the usual PAH clinic routine. The study protocol was approved by each participating center's research ethics board (BRZ 0106-18, SOR0327-16).
At each clinic visit evaluations for both groups were standardized. Each visit included a history, physical and laboratory evaluation, BNP level, 6-minute walk test, and quality of life as assessed using emPHasis 10.
Prior to the decision regarding patient management, the pulmonologist at the PAH clinic knew the test results including a POCUS test done in the intervention group. A change in the patient's management in the clinic is represented by the clinician's recommendation for a change in medication, sending the patient for a lung transplant, hospitalization, or other diagnostic or therapeutic procedure documented
Patients in the intervention group underwent a bedside-focused sonographic assessment of the heart, lungs, abdomen, and IVC in every clinic visit during the period of study. The exam was conducted either at the beginning or after the regular patient assessment. The Investigators used 2-dimensional views, the parasternal long and short axis, subcostal long and IVC, apical 5, 4, 2 chamber view. As this exam was POCUS centered and not a formal cardiac study. When pathologies were identified, relevant measurements were made, and the patient was referred for a formal echo. For example, when a calcified aortic valve was detected, and aortic stenosis was suspected a continuous pulse wave Doppler for maximal velocity measurement was conducted. Standard measurements were for left ventricle wall thickness, size of ventricles and atria, IVC size and collapsibility index, RVSP when TR was identified, TAPSE, and size of pericardial effusion when found. Lung ultrasound was focused on the detection of pulmonary congestion (screening and counting B-lines on both lungs, midclavicular line and midaxillary line), pleural effusion, lung atelectasis, lung consolidations (mid and posterior axillary lines), and sliding of pleura (midclavicular line). The investigators performed Doppler for DVT only within the right clinical context. All POCUS exams were documented in a standardized form. Findings were reported in real-time to the treating pulmonologist and were documented in the follow-up notes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Device: POC-USThe intervention group underwent clinical evaluation and a bedside-focused sonographic assessment |
| control group. | No intervention | –The control group underwent clinical evaluation without POC-US |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with PAH defined by the Updated clinical classification of pulmonary hypertension criteria.
- Age ≥ 18
- Baseline values from right-heart catheterization results for the definite diagnosis of PH: Hemodynamic inclusion: resting mPAP > 25mmHg, PCWP < 15mmHg, and PVR > 3 Woods Units.
Key exclusion criteria (2 listed)
- Inability to give informed consent.
- Clear evidence of Group 2-5 PH. We will also exclude patients with PAH on the basis of congenital heart disease, liver cirrhosis or suspected pulmonary veno-occlusive disease.
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 |
|---|---|---|
| POC-USAlso: clinic visit evaluationsPoint Of Care Ultrasonography (POCUS) is a rapidly evolving bedside modality in which ultrasonography is utilized as a part of the bedside physical examination and the patients' clinical assessment | Device | intervention group |
Primary outcome
percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic
Time frame: 9 monthes
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 18 Apr 2022.
- Derived from this study: PubMed 36902536Avriel A, Bar Lavie Shay A, Hershko Klement A, Taylor J, Shamia D, Tsaban G, Abu-Shakra M, Granton J, Fuchs L. Point-of-Care Ultrasonography in a Pulmonary Hypertension Clinic: A Randomized Pilot Study. J Clin Med. 2023 Feb 22;12(5):1752. doi: 10.3390/jcm12051752.
- Individual participant dataSharing planned: Undecided
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 POC-US in people with POCUS Assessment During Ambulatory PAH Clinic, run by Soroka University Medical Center at 1 site in Israel.
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 2 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 18 Apr 2022. 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 Israel. 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?
percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic (time frame: 9 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332847, which also lists 1 linked publication.
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 18 Apr 2022.