Course and Complications of Invasive Out-of-hospital Ventilation
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.
Indication for Invasive Out-of-hospital Ventilation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung|
- Respiratory Incidences [ Time Frame: Over a 12-month period, monthly ] [ Designated as safety issue: No ]
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.
|Study Start Date:||January 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Patients with invasive out-of-hospital ventilation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755039
|Wissenschaftliches Institut Bethanien e.V.|
|Solingen, Germany, 42699|
|Principal Investigator:||Winfried J Randerath, Prof. Dr.||Wissenschaftliches Institut Bethanien e.V|