Cardiovascular DiseaseWeaning TTENCT02569385
Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning
An observational study of Cardiovascular Disease, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Spontaneous breathing trial
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in prolonged weaning (Group 3 by Boles) with NYHA I-II, who come to the Department of Intensive Care Medicine RTWH Aachen University, will be recruited in the study. Recruitment will be performed in accordance to the inculsion and exclusion criteria.
Who may be able to join
- legal Age (≥18 years)
- written informed consent Prior to study participation
- patient in prolonged weaning with NYHA I-II and an actual positive Ventilator Screening test:
- PaO2 ≥ 60 mmHg at FiO2 ≤ 0.4
- PEEP ≤ 8 cmH2O
- Glasgow Coma Scale > 13
Show all 12Show fewer
- Temp. < 38°C
- Hb > 80-100 g/L
- less requirement on catecholamines (<0.1µg/kg/min)
- and on these patients are already performed a spontaneous breathing trial with following result:
- abortion this spontaneous breathing trial < 30min, but possible > 10min
- reason for an abortion was NOT hypercapnia
Who cannot join
- weaning patients are assigned on Group 1-2
- patient with heart failure (NYHA III-IV) and/ or other cardiac comorbidity
- acute NSTEMI (non-ST-segment elevation myocardial infarction)
- pregnancy and breast-feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen, Department of Medical Clinic I
Aachen
Michael Dreher, MD
Johannes Bickenbach, MD
About this study
The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.
- Conditions
- Cardiovascular Disease
- Being tested
- Spontaneous breathing trial
- Keywords
- Weaning TTE, patients in prolonged weaning
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous breathing trialOther
| Study group | Role | What they receive |
|---|---|---|
| spontaneous breathing trials | spontaneous breathing trials in patients with prolonged weaning Receives: Other: Spontaneous breathing trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning
under pressure support Ventilation are determined some measurement (e.g. breathing rate)
Measured: 12 months
Secondary outcomes (1)
Intervention measurement in patient with prolonged weaning
20 min breathing without mechanical ventilation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, MD, Principal investigator, Uniklinik RWTH Aachen, Med. Klinik I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569385
- Sponsor's protocol ID
- CTC-A 15-034
- Acronym
- Weaning TTE
- Status last verified
- Aug 2015
- First submitted
- 23 Sep 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning
- ClinicalTrials.gov ID
- NCT02569385
- Acronym / sponsor ID
- Weaning TTE / CTC-A 15-034
- Conditions
- Cardiovascular Disease
- Keywords
- Weaning TTE, patients in prolonged weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- 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.
The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spontaneous breathing trials | – | Other: Spontaneous breathing trialspontaneous breathing trials in patients with prolonged weaning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in prolonged weaning (Group 3 by Boles) with NYHA I-II, who come to the Department of Intensive Care Medicine RTWH Aachen University, will be recruited in the study. Recruitment will be performed in accordance to the inculsion and exclusion criteria.
Key inclusion criteria (12 listed)
- legal Age (≥18 years)
- written informed consent Prior to study participation
- patient in prolonged weaning with NYHA I-II and an actual positive Ventilator Screening test:
- and on these patients are already performed a spontaneous breathing trial with following result:
Key exclusion criteria (4 listed)
- weaning patients are assigned on Group 1-2
- patient with heart failure (NYHA III-IV) and/ or other cardiac comorbidity
- acute NSTEMI (non-ST-segment elevation myocardial infarction)
- pregnancy and breast-feeding
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 |
|---|---|---|
| Spontaneous breathing trial | Other | spontaneous breathing trials |
Primary outcome
Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning
Time frame: 12 months
under pressure support Ventilation are determined some measurement (e.g. breathing rate)
1 secondary outcome
Intervention measurement in patient with prolonged weaning
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Michael Dreher, MD principal investigator
Uniklinik RWTH Aachen, Med. Klinik I
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 Cardiovascular Disease, run by RWTH Aachen University 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 12 inclusion and 4 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 6 Oct 2015. 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 Michael Dreher, MD (+49 241 80 88763, mdreher@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning (time frame: 12 months). 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 6 Oct 2015.