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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• Germany
  • Solingen, Germany, 42699
    • Wissenschaftliches Institut Bethanien e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with indication for out-of-hospital ventilation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age <18 years
• absence of declaration of consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Incidences	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.	Over a 12-month period, monthly

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: WI_Heimbeatmung_61/2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No