Course and Complications of Invasive Out-of-hospital Ventilation

Completed

• Conditions: Indication for Invasive Out-of-hospital Ventilation

• Registration Number: NCT01755039
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-03-09
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2012-12-18
• Last Update Submitted: 2012-12-18
• Study First Posted: 2012-12-21
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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

Exclusion Criteria

• Age <18 years
• absence of declaration of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Incidences	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.

Trial Locations

Locations (1)

Wissenschaftliches Institut Bethanien e.V.; 🇩🇪 Solingen, Germany