Examination of Cardiovascular Function/ Cardio Respirator... | NCT02569385

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

NCT02569385

Sponsor

RWTH Aachen University

Status

Unknown status

Last Update Posted

Oct 6, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Spontaneous breathing trial

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Sep 23, 2015

First Submission Date that Met QC Criteria

Oct 2, 2015

First Posted Date

Oct 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2015

Last Update Posted Date

Oct 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spontaneous breathing trials		spontaneous breathing trials in patients with prolonged weaning	Other: Spontaneous breathing trial

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spontaneous breathing trial	Other		spontaneous breathing trials

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Dreher, MD	Contact	+49 241 80 88763		mdreher@ukaachen.de

Overall Officials

Name	Affiliation	Role
Michael Dreher, MD	Uniklinik RWTH Aachen, Med. Klinik I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital RWTH Aachen, Department of Medical Clinic I	Recruiting	Aachen			Germany