Course and Complications of Invasive Out-of-hospital Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT01755039
First received: March 9, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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
Indication for Invasive Out-of-hospital Ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung

Further study details as provided by Wissenschaftliches Institut Bethanien e.V:

Primary Outcome Measures:
  • Respiratory Incidences [ Time Frame: Over a 12-month period, monthly ] [ Designated as safety issue: No ]

    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.



Enrollment: 59
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01755039     History of Changes
Other Study ID Numbers: WI_Heimbeatmung_61/2009
Study First Received: March 9, 2012
Last Updated: December 18, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 15, 2014