Tracheotomy With and Without Dual Antiplatelet Therapy

Recruiting

• Conditions: Tracheostomy Hemorrhage
• Interventions: Device: Tracheotomy

• Registration Number: NCT05058469
• Lead Sponsor: Asklepios Neurological Clinic Bad Salzhausen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-27
• Study Start: 2022-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tracheotomy under antiplatelet therapy+technique 2	Tracheotomy	-
Tracheotomy without antiplatelet therapy+technique 1	Tracheotomy	-
Tracheotomy under antiplatelet therapy+technique 1	Tracheotomy	-
Tracheotomy without antiplatelet therapy+technique 2	Tracheotomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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 days	cartilage pin fractures seen in endoscopy

Trial Locations

Locations (1)

Neurologische Klinik Bad Salzhausen; 🇩🇪 Nidda, Germany