Tracheotomy With and Without Dual Antiplatelet Therapy

NCT05058469 | Unknown

• 1 other identifier: PDT and (D)APT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - 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

Study Arms (4)

Tracheotomy without antiplatelet therapy+technique 1

Device: Tracheotomy

Tracheotomy under antiplatelet therapy+technique 1

Device: Tracheotomy

Tracheotomy without antiplatelet therapy+technique 2

Device: Tracheotomy

Tracheotomy under antiplatelet therapy+technique 2

Device: Tracheotomy

Interventions

Tracheotomy DEVICE

Tracheotomy in patients +/- antiplatelet therapy

Tracheotomy under antiplatelet therapy+technique 1; Tracheotomy under antiplatelet therapy+technique 2; Tracheotomy without antiplatelet therapy+technique 1; Tracheotomy without antiplatelet therapy+technique 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.

You may qualify if:

• Patients who underwent Percutaneous Dilational Tracheostomy

You may not qualify if:

• none

Sponsors & Collaborators

• Asklepios Neurological Clinic Bad Salzhausen: lead

Study Sites (1)

Neurologische Klinik Bad Salzhausen

Nidda, 63667, Germany

RECRUITING

MeSH Terms

Interventions

Tracheotomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Central Study Contacts

Dirk Bandorski, MD

CONTACT

+496043804212; d.bandorski@asklepios.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 27, 2021
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)