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

Cardiovascular Disease Clinical Trial

— Weaning TTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02569385
• Other study ID #: CTC-A 15-034
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2015
• Last updated: October 2, 2015
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: RWTH Aachen University
• Contact: Michael Dreher, MD
• Phone: +49 241 80 88763
• Email: mdreher[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Spontaneous breathing trial

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen, Department of Medical Clinic I	Aachen, 52074

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning	under pressure support Ventilation are determined some measurement (e.g. breathing rate)	12 months	No
Secondary	Intervention measurement in patient with prolonged weaning	20 min breathing without mechanical ventilation	12 months	No