Tracheotomy With and Without Dual Antiplatelet Therapy (PDT and (D)APT)

December 6, 2023 updated by: Asklepios Neurological Clinic Bad Salzhausen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Nidda, Germany, 63667
        • Recruiting
        • Neurologische Klinik Bad Salzhausen
        • Contact:
        • Contact:
          • Jens Allendörfer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tracheotomy without antiplatelet therapy+technique 1
Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy under antiplatelet therapy+technique 1
Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy without antiplatelet therapy+technique 2
Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Tracheotomy under antiplatelet therapy+technique 2
Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP).
Time Frame: 3 days
  • bleeding (yes/no)
  • intervention (yes/no)
  • decrease (>= 1 g/dl) of hemoglobin (yes/no)
  • number of blood transfusion(s)
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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?
Time Frame: 14 days
cartilage pin fractures seen in endoscopy
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios Neurological Clinic Bad Salzhausen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDT and (D)APT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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