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Tracheotomy With and Without Dual Antiplatelet Therapy

Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05058469
Acronym
PDT and (D)APT
Enrollment
300
Registered
2021-09-27
Start date
2022-10-01
Completion date
2024-12-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy Hemorrhage

Brief summary

Platelet-inhibiting drugs are often used after vascular interventions. Patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. For long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (PDT). As part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. In addition, there are various techniques for performing a PDT. The current study aims to investigate the frequency of bleeding/complications taking into account the technique used in PDT.

Interventions

DEVICETracheotomy

Tracheotomy in patients +/- antiplatelet therapy

Sponsors

Asklepios Neurological Clinic Bad Salzhausen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP).3 days* bleeding (yes/no) * intervention (yes/no) * decrease (\>= 1 g/dl) of hemoglobin (yes/no) * number of blood transfusion(s)

Secondary

MeasureTime frameDescription
- Does the technique of PDT affect the bleeding rate? - How often are recognizable cartilage pin fractures in the context of a PDT? - Influence of AP and PDT technology on the frequency of need for a blood transfusion?14 dayscartilage pin fractures seen in endoscopy

Countries

Germany

Contacts

Primary ContactDirk Bandorski, MD
d.bandorski@asklepios.com+496043804212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026