DyspneaNCT05729035
POCUS VS CT in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients
An observational study of Dyspnea and Chronic Renal Failure, run by Randa Ahmed Sarhan.
Trial summary
Estimate the predictive value of POCUS in diagnosis of different causes of acute dyspnea in hemodialysis patients and compare between POCUS and CT in differentiation the causes of acute dyspnea in those population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyspnea, Chronic Renal Failure
- What is being tested?
- POCUS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Apr 2024
- Phase
- Observational
- 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
Study population: - All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea.
Who may be able to join
- All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea.
Who cannot join
- • Age less than 18
- Diagnosed chronic pulmonary disease.
- Severe heart failure (NYHA class IV).
- Active malignancy.
- Pregnancy.
- Hepatic Failure (Child B,C).
- Comatosed Patients.
Trial locations and contacts
No sites are listed yet.
Asharaf EL-shazly EL-shazly contact
About this study
Official title: Predictive Value of Point of Care Ultrasound (POCUS) Versus Computerized Tomography (CT) in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients.
Estimate the predictive value of POCUS in diagnosis of different causes of acute dyspnea in hemodialysis patients and compare between POCUS and CT in differentiation the causes of acute dyspnea in those population.
Read the detailed description
Dyspnea is "a subjective experience of breathing discomfort that consists of qualitatively dis-tinct sensations that vary in intensity.Dyspnea is a common symptom both in general practice and in hospital emergency rooms. It has been reported that 7.4% of patients presenting to emergency rooms complain of dyspnea;among patients in general practice, 10% complain of dyspnea when walking on flat ground and 25% complain of dyspnea on more intense exertion, e.g., climbing stairs.Dyspnea is considered acute when it develops over hours to days.Acute breathlessness in haemodialysis patients can be caused by various conditions such as acute coronary syndrome, catheter-related infection, pneumonia and pericardial effusion, as well as a reaction to the dialyser or medication given during dialysis Hence, clinical acumen remains integral in evaluation of acute breathlessness in this group of patients. Point of Care Ultrasound is complementary to a medical examination performed by primary care physicians in conjunction to physical examination to investigate unclear findings. As such it is used to find and identify either the presence or absence of specific pathological results seen in your patients.
- Conditions
- Dyspnea, Chronic Renal Failure
- Being tested
- POCUS
- Medical subject headings
- Dyspnea, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUSRadiation
Also called CT chest
Point of Care Ultrasound is complementary to a medical examination performed by primary care physicians
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare between POCUS and CT in differentiation the causes of acute dyspnea in hemodialysis patients.
Predictive value of Point of Care Ultrasound (POCUS) versus computerized tomography (CT) in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients.
Measured: All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randa Ahmed Sarhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randa Ahmed Sarhan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729035
- Sponsor's protocol ID
- POCUS VS CT chest
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smallwood N, Dachsel M. Point-of-care ultrasound (POCUS): unnecessary gadgetry or evidence-based medicine? Clin Med (Lond). 2018 Jun;18(3):219-224. doi: 10.7861/clinmedicine.18-3-219.
PubMed 29858431Li L, Yong RJ, Kaye AD, Urman RD. Perioperative Point of Care Ultrasound (POCUS) for Anesthesiologists: an Overview. Curr Pain Headache Rep. 2020 Mar 21;24(5):20. doi: 10.1007/s11916-020-0847-0.
PubMed 32200432Rice JA, Brewer J, Speaks T, Choi C, Lahsaei P, Romito BT. The POCUS Consult: How Point of Care Ultrasound Helps Guide Medical Decision Making. Int J Gen Med. 2021 Dec 15;14:9789-9806. doi: 10.2147/IJGM.S339476. eCollection 2021.
PubMed 34938102
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Point of Care Ultrasound (POCUS) Versus Computerized Tomography (CT) in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT05729035
- Acronym / sponsor ID
- POCUS VS CT chest
- Conditions
- Dyspnea, Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Randa Ahmed SarhanUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Feb 2023 (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.
Estimate the predictive value of POCUS in diagnosis of different causes of acute dyspnea in hemodialysis patients and compare between POCUS and CT in differentiation the causes of acute dyspnea in those population.
Detailed description
Dyspnea is "a subjective experience of breathing discomfort that consists of qualitatively dis-tinct sensations that vary in intensity.Dyspnea is a common symptom both in general practice and in hospital emergency rooms. It has been reported that 7.4% of patients presenting to emergency rooms complain of dyspnea;among patients in general practice, 10% complain of dyspnea when walking on flat ground and 25% complain of dyspnea on more intense exertion, e.g., climbing stairs.Dyspnea is considered acute when it develops over hours to days.Acute breathlessness in haemodialysis patients can be caused by various conditions such as acute coronary syndrome, catheter-related infection, pneumonia and pericardial effusion, as well as a reaction to the dialyser or medication given during dialysis Hence, clinical acumen remains integral in evaluation of acute breathlessness in this group of patients. Point of Care Ultrasound is complementary to a medical examination performed by primary care physicians in conjunction to physical examination to investigate unclear findings. As such it is used to find and identify either the presence or absence of specific pathological results seen in your patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea.
Key inclusion criteria (1 listed)
- All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea.
Key exclusion criteria (7 listed)
- • Age less than 18
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 |
|---|---|---|
| POCUSAlso: CT chestPoint of Care Ultrasound is complementary to a medical examination performed by primary care physicians | Radiation | – |
Primary outcome
Compare between POCUS and CT in differentiation the causes of acute dyspnea in hemodialysis patients.
Time frame: All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea
Predictive value of Point of Care Ultrasound (POCUS) versus computerized tomography (CT) in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 29858431Smallwood N, Dachsel M. Point-of-care ultrasound (POCUS): unnecessary gadgetry or evidence-based medicine? Clin Med (Lond). 2018 Jun;18(3):219-224. doi: 10.7861/clinmedicine.18-3-219.
- Background: PubMed 32200432Li L, Yong RJ, Kaye AD, Urman RD. Perioperative Point of Care Ultrasound (POCUS) for Anesthesiologists: an Overview. Curr Pain Headache Rep. 2020 Mar 21;24(5):20. doi: 10.1007/s11916-020-0847-0.
- Background: PubMed 34938102Rice JA, Brewer J, Speaks T, Choi C, Lahsaei P, Romito BT. The POCUS Consult: How Point of Care Ultrasound Helps Guide Medical Decision Making. Int J Gen Med. 2021 Dec 15;14:9789-9806. doi: 10.2147/IJGM.S339476. eCollection 2021.
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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.
Asharaf EL-shazly EL-shazly contact
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Chronic Renal Failure, run by Randa Ahmed Sarhan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randa Ahmed Sarhan (01118683728, randaahmedsarhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare between POCUS and CT in differentiation the causes of acute dyspnea in hemodialysis patients. (time frame: All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea). 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 NCT05729035, which also lists 3 linked publications.
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 15 Feb 2023.