COPD Exacerbations

Terminated

• Conditions: COPD

• Registration Number: NCT02798575
• Lead Sponsor: RWTH Aachen University

Brief Summary

Detecting exacerbations to prevent a severe and / or to early treat an exacerbation is crucial in patients with COPD in order to prevent hospitalization. Patients with invasive mechanical ventilation outside the hospital have a high re-hospitalization rate which is associated with severe economic burden since those patients need to be treated mainly on an ICU or a respiratory ward being able to take care of invasive mechanical ventilation.

Recently, it has been shown that daily variations of parameters recorded by non-invasive ventilation (NIV) software are predictors of exacerbations in a cohort of COPD patients being treated outside the hospital with NIV \[1\]. These parameters were respiratory rate and percentage of respiratory cycles triggered by the patient.

The aim of the present study is to detect parameters recorded by the ventilator which are able to predict exacerbation and / or hospitalization in patients with COPD under invasive mechanical ventilation outside the hospital.

Detailed Description

The number of mechanically ventilated patients in the intensive care unit (ICU) is increasing due to a rise in the frequency of respiratory and cardiovascular diseases as well as demographical changes. As a result, there is a corresponding increase in the time required for the complex process of weaning from mechanical ventilation (MV). Weaning from MV contributes to up to 50% of the duration of respiratory support. Especially those patients with prolonged weaning (≥3 spontaneous breathing trials over ≥7 days) refer to a very complex patient group with either chronic co-morbidities (e.g. chronic obstructive pulmonary disease \[COPD\]) or extended treatment in the ICU as a result of acute conditions (e.g. septic or cardiogenic shock, acute respiratory failure) or other significant diseases.

Not all of these patients can be weaned from the ventilator. An increasing number of patients are in need for invasive mechanical ventilation following unsuccessful weaning. They often need special care regarding ventilatory support, management of tracheal secretion and muscular re-conditioning.

These patients, especially those with COPD, are at high risk for further exacerbations and have thus a high rate of re-hospitalization. An early detection of exacerbations to rapidly implement therapeutic interventions is a major goal in the management of patients with severe COPD but may need close contact to medical experts.

However, a physician-based structure for treating this specific patient group does not exist, so that these patients often have hospital treatment. This might be preventable if clinical determinants and ventilator parameters would be detected timely.

Home ventilators for invasive ventilation are provided with built-in software recording data such as respiratory rate (RR), percentage of respiratory cycles triggered by the patient (%Trigg), tidal volume and daily usage of the ventilator. A systematic assessment of variations in specific ventilator-based parameters may help to predict the risk of exacerbation in patients with COPD treated by home care.

In sum, the objective of this study is to assess whether day-to-day variation in these ventilatory parameters recorded by the ventilators can predict an imminent exacerbation or need for hospitalization in patients with COPD treated at home with invasive ventilation. This is supposed to be of major importance, both for the progression of the disease and for economic reasons regarding the health care system. The possibility of detecting exacerbations due to ventilator analysis might be a further step towards telemonitoring of ventilator-dependent patients

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Subjects with COPD indicative for invasive ventilation outside the hospital
2. Male or female aged > 18 years
3. Written informed consent prior to study participation by patient or legal representative

Exclusion Criteria

1. Pregnant and lactating females
2. Indication for invasive ventilation outside the hospital due to other disease than COPD
3. Inability or Unwillingness to give written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of an exacerbation of COPD	up to 12 months	An exacerbation or unplanned hospitalization will be defined as following: Event 1: "Exacerbation without hospital admission" In case of administration of antibiotics and / or steroids by a general practitioner, this event will be defined as exacerbations of COPD.; Event 2: "Critical exacerbation with hospital admission" In case of administration of antibiotics and / or steroids by a general practitioner and an additional hospitalization, this event will also be defined as a critical exacerbation.; Event 3: "Hospital admission without exacerbation" In case of hospitalization for reasons other than exacerbation (e.g. patients dys-synchrony on ventilator, other somatic reasons), this event will also be defined and recorded.

Secondary Outcome Measures

Name	Time	Method
EXACT Pro Questionnaire	up to 12 months	The questionnaire will be performed weekly by patients or legal representative in order to evaluate exacerbations and respiratory symptoms in clinical studies of COPD.
Arterial blood gas (ABG)	baseline, month 3, month 6 and month 12	Blood samples for arterial blood gas analysis (ABG) will be performed at baseline, month 3, month 6 and month 12.
Evaluation of demographic data	baseline, month 3, month 6 and month 12	Demographic data will be recorded and evaluated at baseline, follow up at month 3, month 6 and month 12.
Daily usage of ventilator (in hours)	up to 12 months	Daily usage of ventilator will be recorded by the ventilator daily during home care. Analysis of the recorded data will be performed at month 3, month 6 and month 12.
Tidal volume	up to 12 months	Tidal volume will be recorded by the ventilator daily during home care. Analysis of the recorded data will be performed at month 3, month 6 and month 12.
%Trigg cycled breaths	up to 12 months	%Trigg cycled breaths will be recorded by the ventilator daily during home care. Analysis of the recorded data will be performed at month 3, month 6 and month 12.
Respiratory Rate (RR)	up to 12 months	The RR will be recorded by the ventilator daily during home care. Analysis of the recorded data will be performed at month 3, month 6 and month 12.

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany