Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorAyham Daher

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have a clearly defined indication for Right heart catheterization.

Age > 18 years

Informed consent for participation in the study will sign

Disqualifiers

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

Trial population

All patients receiving right heart catheterization for appropriate indications will be interviewed for their consent to participate in the study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood gas analysis

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: No pulmonary Hypertension1 intervention
Group B: pulmonary Hypertension Group 11 intervention
Group C: pulmonary Hypertension Group 21 intervention
Group D: pulmonary Hypertension Group 31 intervention
Group E: pulmonary Hypertension Group 41 intervention
Group F: pulmonary Hypertension Group 51 intervention

Trial outcomes

Primary outcomes

1

Between group differences

Differences in the Wedge-BGA between groups

Time frame
At the time of recruitment

Secondary outcomes

1

Follow-up

Risk stratification and mortality after 1 and 5 years

Time frame
1 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ayham Daher

Lead sponsor

RWTH Aachen University

Sponsor institution