Tracheostomy HemorrhagePDT and (D)APTNCT05058469
Tracheotomy With and Without Dual Antiplatelet Therapy
An observational study of Tracheostomy Hemorrhage, run by Asklepios Neurological Clinic Bad Salzhausen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Hemorrhage
- What is being tested?
- Tracheotomy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.
Who may be able to join
- Patients who underwent Percutaneous Dilational Tracheostomy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neurologische Klinik Bad Salzhausen
Nidda, 63667
Dirk Bandorski, MD, +496043804212, d.bandorski@asklepios.com
Jens Allendörfer, MD
About this study
Official title: 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.
- Conditions
- Tracheostomy Hemorrhage
- Being tested
- Tracheotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheotomyDevice
Tracheotomy in patients +/- antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| Tracheotomy without antiplatelet therapy+technique 1 | Not described Receives: Device: Tracheotomy | |
| Tracheotomy under antiplatelet therapy+technique 1 | Not described Receives: Device: Tracheotomy | |
| Tracheotomy without antiplatelet therapy+technique 2 | Not described Receives: Device: Tracheotomy | |
| Tracheotomy under antiplatelet therapy+technique 2 | Not described Receives: Device: Tracheotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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?
cartilage pin fractures seen in endoscopy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios Neurological Clinic Bad Salzhausen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058469
- Sponsor's protocol ID
- PDT and (D)APT
- Acronym
- PDT and (D)APT
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques
- ClinicalTrials.gov ID
- NCT05058469
- Acronym / sponsor ID
- PDT and (D)APT / PDT and (D)APT
- Conditions
- Tracheostomy Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asklepios Neurological Clinic Bad SalzhausenUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.
Key inclusion criteria (1 listed)
- Patients who underwent Percutaneous Dilational Tracheostomy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TracheotomyTracheotomy in patients +/- antiplatelet therapy | Device | Tracheotomy under antiplatelet therapy+technique 1, Tracheotomy under antiplatelet therapy+technique 2, Tracheotomy without antiplatelet therapy+technique 1, Tracheotomy without antiplatelet therapy+technique 2 |
Primary outcome
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)
1 secondary outcome
- 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Hemorrhage, run by Asklepios Neurological Clinic Bad Salzhausen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Bandorski, MD (+496043804212, d.bandorski@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP). (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.