Completed

NCT Number: NCT01755039

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.

Completed

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Key information

Conditions

Indication for Invasive Out-of-hospital Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wissenschaftliches Institut Bethanien e.V.

Solingen, 42699, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Age <18 years
absence of declaration of consent

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Official study title

Verlauf Und Respiratorische Zwischenfälle Bei Patienten Mit außerklinischer Beatmung

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Dec 21, 2012
Registry last updated: Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.