Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)
Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization
1 other identifier
observational
100
1 country
1
Brief Summary
If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2021
CompletedFirst Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
February 6, 2026
January 1, 2026
5 years
July 30, 2021
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Between group differences
Differences in the Wedge-BGA between groups
At the time of recruitment
Secondary Outcomes (1)
Follow-up
1 and 5 years
Study Arms (6)
No pulmonary Hypertension
pulmonary Hypertension Group 1
pulmonary Hypertension Group 2
pulmonary Hypertension Group 3
pulmonary Hypertension Group 4
pulmonary Hypertension Group 5
Interventions
Two blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later.
Eligibility Criteria
All patients receiving right heart catheterization for appropriate indications will be interviewed for their consent to participate in the study
You may qualify if:
- Patients who have a clearly defined indication for Right heart catheterization.
- Age \> 18 years
- Informed consent for participation in the study will sign
You may not qualify if:
- Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study
- Pregnancy and lactation
- Wedge-BGA not possible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ayham Daherlead
Study Sites (1)
University Hospital RWTH Aachen
Aachen, 52062, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 6, 2021
Study Start
June 25, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 6, 2026
Record last verified: 2026-01