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Course and Complications of Invasive Out-of-hospital Ventilation

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ClinicalTrials.gov Identifier: NCT01755039
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Brief Summary:
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.

Condition or disease
Indication for Invasive Out-of-hospital Ventilation

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung
Study Start Date : January 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients with invasive out-of-hospital ventilation



Primary Outcome Measures :
  1. Respiratory Incidences [ Time Frame: Over a 12-month period, monthly ]

    Incidences comprise:

    permanent alarming by the ventilator, malfunction of the ventilator, use of an AMBU bag, dyspnoea, worsening of general condition, desaturation of 5 % or more in relation to average saturation of the patients, disconnection of the ventilator, increase of tracheal secretion, reanimation, replacement of tracheal canula, other emergency, call of emergency doctor, call of pneumologist, unscheduled home visit of the patient by a doctor, use of antibiotics, use ov steroids, use of opiates, changing of the ventilator settings, hospital transfer, death.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with indication for out-of-hospital ventilation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years
  • absence of declaration of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755039


Locations
Germany
Wissenschaftliches Institut Bethanien e.V.
Solingen, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Investigators
Principal Investigator: Winfried J Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V

Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01755039     History of Changes
Other Study ID Numbers: WI_Heimbeatmung_61/2009
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012