Pulmonary HypertensionNCT07154927
Evaluation of Feasibility of Ultrasonography Guided Pulmonary Artery Catheterization in Pulmonary Hypertension Diagnosis
An observational study of Pulmonary Hypertension, run by Mostafa K. Ahmed at 1 site in Egypt.
Trial summary
Pulmonary artery catheters (PACs) that called Swan-Ganz catheters provide valuable information in select patient's especially pulmonary hypertension patiens. PACs are indicated for assessment of cardiopulmonary hemodynamics in specific groups of patients presenting with pulmonary hypertension, pulmonary embolism or… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pulmonary hypertension patients refered to our pulmonary hyperetnsion unit for PAC
Who may be able to join
- Adults (≥18 years)
- Clinically suspected PH referred for diagnostic RHC
- Informed consent provided
- ### Exclusion Criteria
- Hemodynamic instability requiring immediate intervention
- Poor echocardiographic window despite TTE/TEE
Show all 9Show fewer
- Contraindications to catheterization
- Known intracardiac shunts or severe tricuspid regurgitation (if it impairs catheter tracking)
- iteria: -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University , Faculty of medicine, Chest Diseases; Pulmonary hypertension UNIT
Asyut, Select A State, 71515
mostafa K. Ahmed, MD(associate professor), 01017035635, mostafak198173@yahoo.com
About this study
Official title: Evaluation of the Feasibility of Ultrasonography Guided Pulmonary Artery Catheterization in Pulmonary Hypertension Diagnosis.Pulmonary Artery Catheters (PACs) That Called Swan-Ganz Catheters Provide Valuable Information in Select Patient's Especially Pulmonary Hypertension Patiens. PACs Are Indicated for Assessment of Cardiopulmonary Hemodynamics in Specific Groups of Patients Presenting With Pulmonary Hypertension, Pulmonary Embolism or Shock [1]. They Can be Inserted at Bedside Under Sterile Conditions and Provide Valuable Information That Can Add Benefit for Measures Recorded With Transthor
Pulmonary artery catheters (PACs) that called Swan-Ganz catheters provide valuable information in select patient's especially pulmonary hypertension patiens. PACs are indicated for assessment of cardiopulmonary hemodynamics in specific groups of patients presenting with pulmonary hypertension, pulmonary embolism or shock [1]. They can be inserted at bedside under sterile conditions and provide valuable information that can add benefit for measures recorded with transthoracic echocardiography. The advancement of PACs in a patient is usually performed by flotation of a balloon tipped catheter under pressure waveform guidance. The balloon tip floats in blood and is directed into the pulmonary artery by the normal flow from superior vena cava and through the right heart chambers into pulmonary artery. The correct positioning is needed for safe use and accurate cardiopulmonary hemodynamics measurement. The use of blind approach of insertion can be challenging in patients with slow blood flow as pulmonary hypertension patients. The abnormal flow can induce the PAC to coil in cardiac chambers such as right atrium and right ventricle or be misdirected to the inferior vena cava. Repeated attempts to retract and redirect the catheter can increase the risk of complications and should be avoided [2]. The use of fluoroscopic guidance persists in these cases. Fluoroscopy when used alongside pressure waveform analysis has been noted to reduce the time to wedge, number of attempts and composite complication rate in patients undergoing pulmonary hemodynamic assessment. Also, fluoroscopy provides real time visualization that can lead to reduction of catheter malposition and ventricular arrhythmias. Unfortunately, it is not available in all pulmonary hypertension units for bedside insertion and hemodynamics evaluation. The use of fluoroscopy can led to unnecessary radiation exposure to both the patient and the procedure team. Sonographic guided pulmonary catheter insertion is interesting technique ; however it still needed to be studied in pulmonary hypertension patients in pulmonary hypertension unit
Read the detailed description
pulmonary artery catheterization for hemodynamics assessment patients with suggestion of having certain pulmonary hypertensions groups is vital for establishing their managements; few tools are used to facilitate catheter insertion including monitor waves form, fluoroscopic guidance and to lesser extent sonographics guidance. sonographic guidance is not fully studied in pulmonary hypertenison patients however it carries advantages over radiographic guidance of being less exposure to radiation for both the patients and health care team. with increasing pulmonary hypertension units allover the worlds and patients recognitions in addition to availability of ultrasonography that necessitate this study to evaluate sonographic guidance in pulmonary hypertension patients
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary artery catheterization , ultrasonography guidance
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate** of PAC placement using ultrasound guidance alone
Time to catheter placement (in minutes)
- Incidence of complications (major and minor)
- Accuracy of hemodynamic parameters compared to standard reference
- Learning curve evaluation over time
Measured: procedure time from starting patient puncture till procedure end (PAC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start30 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mostafa K. Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa K. Ahmed, Assiut University
- Investigators
- mostafa K Ahmed, MD, Principal investigator, Assiut University pulmonary hypertension Unit Chest Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154927
- Sponsor's protocol ID
- ASSIUTMOSTAFAKAHMED
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Ultrasonography Guided Pulmonary Artery Catheterization in Pulmonary Hypertension Diagnosis.Pulmonary Artery Catheters (PACs) That Called Swan-Ganz Catheters Provide Valuable Information in Select Patient's Especially Pulmonary Hypertension Patiens. PACs Are Indicated for Assessment of Cardiopulmonary Hemodynamics in Specific Groups of Patients Presenting With Pulmonary Hypertension, Pulmonary Embolism or Shock [1]. They Can be Inserted at Bedside Under Sterile Conditions and Provide Valuable Information That Can Add Benefit for Measures Recorded With Transthor
- ClinicalTrials.gov ID
- NCT07154927
- Acronym / sponsor ID
- ASSIUTMOSTAFAKAHMED
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary artery catheterization , ultrasonography guidance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mostafa K. AhmedUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Sep 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.
Pulmonary artery catheters (PACs) that called Swan-Ganz catheters provide valuable information in select patient's especially pulmonary hypertension patiens. PACs are indicated for assessment of cardiopulmonary hemodynamics in specific groups of patients presenting with pulmonary hypertension, pulmonary embolism or shock [1]. They can be inserted at bedside under sterile conditions and provide valuable information that can add benefit for measures recorded with transthoracic echocardiography. The advancement of PACs in a patient is usually performed by flotation of a balloon tipped catheter under pressure waveform guidance. The balloon tip floats in blood and is directed into the pulmonary artery by the normal flow from superior vena cava and through the right heart chambers into pulmonary artery. The correct positioning is needed for safe use and accurate cardiopulmonary hemodynamics measurement. The use of blind approach of insertion can be challenging in patients with slow blood flow as pulmonary hypertension patients. The abnormal flow can induce the PAC to coil in cardiac chambers such as right atrium and right ventricle or be misdirected to the inferior vena cava. Repeated attempts to retract and redirect the catheter can increase the risk of complications and should be avoided [2]. The use of fluoroscopic guidance persists in these cases. Fluoroscopy when used alongside pressure waveform analysis has been noted to reduce the time to wedge, number of attempts and composite complication rate in patients undergoing pulmonary hemodynamic assessment. Also, fluoroscopy provides real time visualization that can lead to reduction of catheter malposition and ventricular arrhythmias. Unfortunately, it is not available in all pulmonary hypertension units for bedside insertion and hemodynamics evaluation. The use of fluoroscopy can led to unnecessary radiation exposure to both the patient and the procedure team. Sonographic guided pulmonary catheter insertion is interesting technique ; however it still needed to be studied in pulmonary hypertension patients in pulmonary hypertension unit
Detailed description
pulmonary artery catheterization for hemodynamics assessment patients with suggestion of having certain pulmonary hypertensions groups is vital for establishing their managements; few tools are used to facilitate catheter insertion including monitor waves form, fluoroscopic guidance and to lesser extent sonographics guidance. sonographic guidance is not fully studied in pulmonary hypertenison patients however it carries advantages over radiographic guidance of being less exposure to radiation for both the patients and health care team. with increasing pulmonary hypertension units allover the worlds and patients recognitions in addition to availability of ultrasonography that necessitate this study to evaluate sonographic guidance in pulmonary hypertension patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pulmonary hypertension patients refered to our pulmonary hyperetnsion unit for PAC
Key inclusion criteria (9 listed)
- Adults (≥18 years)
- Clinically suspected PH referred for diagnostic RHC
- Informed consent provided
- ### Exclusion Criteria
- Hemodynamic instability requiring immediate intervention
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate** of PAC placement using ultrasound guidance alone
Time frame: procedure time from starting patient puncture till procedure end (PAC)
Time to catheter placement (in minutes) * Incidence of complications (major and minor) * Accuracy of hemodynamic parameters compared to standard reference * Learning curve evaluation over time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Assiut University , Faculty of medicine, Chest Diseases; Pulmonary hypertension UNIT
Asyut, Egypt
mostafa K Ahmed, MD principal investigator
Assiut University pulmonary hypertension Unit Chest Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Mostafa K. Ahmed at 1 site in Egypt.
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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate** of PAC placement using ultrasound guidance alone (time frame: procedure time from starting patient puncture till procedure end (PAC)). 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 26 Aug 2026.