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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

March 9, 2012
December 21, 2012
December 21, 2012
January 2009
December 2012   (Final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
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Course and Complications of Invasive Out-of-hospital Ventilation
Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with indication for out-of-hospital ventilation
Indication for Invasive Out-of-hospital Ventilation
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Patients with invasive out-of-hospital ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years
  • absence of declaration of consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01755039
WI_Heimbeatmung_61/2009
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Wissenschaftliches Institut Bethanien e.V
Wissenschaftliches Institut Bethanien e.V
Not Provided
Principal Investigator: Winfried J Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V
Wissenschaftliches Institut Bethanien e.V
December 2012