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

NCT02569385 | Unknown

• 1 other identifier: CTC-A 15-034
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Weaning TTE; patients in prolonged weaning

Outcome Measures

Primary Outcomes (1)

• Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning

  under pressure support Ventilation are determined some measurement (e.g. breathing rate)

  12 months

Secondary Outcomes (1)

• Intervention measurement in patient with prolonged weaning

  12 months

Study Arms (1)

spontaneous breathing trials

spontaneous breathing trials in patients with prolonged weaning

Other: Spontaneous breathing trial

Interventions

Spontaneous breathing trial OTHER

spontaneous breathing trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen, Department of Medical Clinic I

Aachen, Germany

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Michael Dreher, MD

  Uniklinik RWTH Aachen, Med. Klinik I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dreher, MD

CONTACT

+49 241 80 88763; mdreher@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 6, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 6, 2015

Record last verified: 2015-08

Locations

DE (1)