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

NCT04993612 — Recruiting, 100 participants, Ayham Daher

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Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization

RegistryNCT04993612
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorAyham Daher (Other)
ConditionsPulmonary Hypertension
InterventionsBlood gas analysis (Diagnostic test)
Datesstart 2021-06-25, primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2021-08-06, last updated 2026-02-06
Locations1 site in Germany

Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Hypertension All trials of Blood gas analysis

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
No pulmonary HypertensionDiagnostic Test: Blood gas analysis
pulmonary Hypertension Group 1Diagnostic Test: Blood gas analysis
pulmonary Hypertension Group 2Diagnostic Test: Blood gas analysis
pulmonary Hypertension Group 3Diagnostic Test: Blood gas analysis
pulmonary Hypertension Group 4Diagnostic Test: Blood gas analysis
pulmonary Hypertension Group 5Diagnostic Test: Blood gas analysis
  • 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.

+Outcome measures

Primary outcomes

  • Between group differences [At the time of recruitment]: Differences in the Wedge-BGA between groups

Secondary outcomes

  • Follow-up [1 and 5 years]: Risk stratification and mortality after 1 and 5 years

+Eligibility

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

* Patients who have a clearly defined indication for Right heart catheterization.
* Age > 18 years
* Informed consent for participation in the study will sign

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
University Hospital RWTH AachenAachenGermanyRecruiting