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Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning (Weaning TTE)

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ClinicalTrials.gov Identifier: NCT02569385
Recruitment Status : Unknown
Verified August 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Other: Spontaneous breathing trial

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Group/Cohort Intervention/treatment
spontaneous breathing trials
spontaneous breathing trials in patients with prolonged weaning
Other: Spontaneous breathing trial



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Intervention measurement in patient with prolonged weaning [ Time Frame: 12 months ]
    20 min breathing without mechanical ventilation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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:

    1. PaO2 ≥ 60 mmHg at FiO2 ≤ 0.4
    2. PEEP ≤ 8 cmH2O
    3. Glasgow Coma Scale > 13
    4. Temp. < 38°C
    5. Hb > 80-100 g/L
    6. less requirement on catecholamines (<0.1µg/kg/min)
  • and on these patients are already performed a spontaneous breathing trial with following result:

    1. abortion this spontaneous breathing trial < 30min, but possible > 10min
    2. reason for an abortion was NOT hypercapnia

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569385


Contacts
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Contact: Michael Dreher, MD +49 241 80 88763 mdreher@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen, Department of Medical Clinic I Recruiting
Aachen, 52074, Germany
Principal Investigator: Michael Dreher, MD         
Sub-Investigator: Johannes Bickenbach, MD         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Michael Dreher, MD Uniklinik RWTH Aachen, Med. Klinik I
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02569385    
Other Study ID Numbers: CTC-A 15-034
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: August 2015
Keywords provided by RWTH Aachen University:
Weaning TTE
patients in prolonged weaning
Additional relevant MeSH terms:
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Cardiovascular Diseases