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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05058469
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Asklepios Neurological Clinic Bad Salzhausen

Tracking Information
First Submitted Date September 14, 2021
First Posted Date September 27, 2021
Last Update Posted Date December 8, 2023
Actual Study Start Date October 1, 2022
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2021)		 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)
Original Primary Outcome Measures
 (submitted: September 23, 2021)		 Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP). [ Time Frame: 3 days ]
clinical signs of bleeding decrease of hemoglobin need of blood transfusion
Change History
Current Secondary Outcome Measures
 (submitted: September 23, 2021)		 - 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tracheotomy With and Without Dual Antiplatelet Therapy
Official Title Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.
Condition Tracheostomy Hemorrhage
Intervention Device: Tracheotomy
Tracheotomy in patients +/- antiplatelet therapy
Study Groups/Cohorts
  • Tracheotomy without antiplatelet therapy+technique 1
    Intervention: Device: Tracheotomy
  • Tracheotomy under antiplatelet therapy+technique 1
    Intervention: Device: Tracheotomy
  • Tracheotomy without antiplatelet therapy+technique 2
    Intervention: Device: Tracheotomy
  • Tracheotomy under antiplatelet therapy+technique 2
    Intervention: Device: Tracheotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 23, 2021)		 300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Dirk Bandorski, MD +496043804212 d.bandorski@asklepios.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT05058469
Other Study ID Numbers PDT and (D)APT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Asklepios Neurological Clinic Bad Salzhausen
Original Responsible Party Same as current
Current Study Sponsor Asklepios Neurological Clinic Bad Salzhausen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Asklepios Neurological Clinic Bad Salzhausen
Verification Date December 2023