Tracheotomy With and Without Dual Antiplatelet Therapy

Tracheostomy Hemorrhage Clinical Trial

— PDT and (D)APT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058469
• Other study ID #: PDT and (D)APT
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Asklepios Neurological Clinic Bad Salzhausen
• Contact: Dirk Bandorski, MD
• Phone: +496043804212
• Email: d.bandorski[@]asklepios.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Hemorrhage
• Tracheostomy Hemorrhage

Intervention

Device:
• Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy

Locations

Country	Name	City	State
Germany	Neurologische Klinik Bad Salzhausen	Nidda

Sponsors (1)

Lead Sponsor	Collaborator
Asklepios Neurological Clinic Bad Salzhausen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP).	bleeding (yes/no); intervention (yes/no); decrease (>= 1 g/dl) of hemoglobin (yes/no); number of blood transfusion(s)	3 days
Secondary	- 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?	cartilage pin fractures seen in endoscopy	14 days