Course and Complications of Invasive Out-of-hospital Ventilation

NCT ID: NCT01755039

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the study is to determine the frequency and management of respiratory incidence in patients with invasive out-of-hospital ventilation, either living at home for elderly people allay to a weaning centre or at home. Further, the mortality and the frequency of hospital admission will be analyzed.

Detailed Description

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Background: There has been arise in a number of patients requiring long term ventilation both in the in-hospital as well as the out-of-hospital setting. Despite this, little is known about the subsequent political course of this patients following hospital discharge.

Interventions: This is an observational prospective study over a period of one year in a sample of 50 to 70 invasively ventilated patients living either in a nursing home specialized in the care of ventilated patients or at home. Protocol had been developed containing 20 suspected emergency incidences in respiratory care. The nursing staffs are instructed about the study and how to complete the protocol. The protocol was placed at each patient and every time an emergency occurred, the nursing staff registered the incidence. If an emergency fulfils more than one criterion in the protocol, every applicable criterion was marked. The data will be analyzed using non-parametric descriptive statistics.

Conditions

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Indication for Invasive Out-of-hospital Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with invasive out-of-hospital ventilation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years
* existing out-of-hospital ventilation \>6h in 24h

Exclusion Criteria

* Age \<18 years
* absence of declaration of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried J Randerath, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Wissenschaftliches Institut Bethanien e.V

Locations

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Wissenschaftliches Institut Bethanien e.V.

Solingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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WI_Heimbeatmung_61/2009

Identifier Type: -

Identifier Source: org_study_id