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

October 2, 2015 updated by: RWTH Aachen University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Locations

  • Germany
      • Aachen, 52074, Germany
        • Recruiting
        • University Hospital RWTH Aachen, Department of Medical Clinic I
        • Principal Investigator:
          • Michael Dreher, MD
        • Sub-Investigator:
          • Johannes Bickenbach, 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

Yes

Genders Eligible for Study

All

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.

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention measurement in patient with prolonged weaning
Time Frame: 12 months
20 min breathing without mechanical ventilation
12 months

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Dreher, MD, Uniklinik RWTH Aachen, Med. Klinik I

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

August 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-A 15-034

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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