- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02798575
COPD Exacerbations
Detecting Chronic Obstructive Pulmonary Disease (COPD) Exacerbations and Need for Hospitalization With Software Analysis of Ventilators for Invasive Mechanical Ventilation
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- University Hospital RWTH Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects with COPD indicative for invasive ventilation outside the hospital
- Male or female aged > 18 years
- Written informed consent prior to study participation by patient or legal representative
Exclusion Criteria:
- Pregnant and lactating females
- Indication for invasive ventilation outside the hospital due to other disease than COPD
- Inability or Unwillingness to give written informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of an exacerbation of COPD
Time Frame: 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. |
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EXACT Pro Questionnaire
Time Frame: 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.
|
up to 12 months
|
Arterial blood gas (ABG)
Time Frame: 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.
|
baseline, month 3, month 6 and month 12
|
Evaluation of demographic data
Time Frame: 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.
|
baseline, month 3, month 6 and month 12
|
Daily usage of ventilator (in hours)
Time Frame: 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.
|
up to 12 months
|
Tidal volume
Time Frame: 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.
|
up to 12 months
|
%Trigg cycled breaths
Time Frame: 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.
|
up to 12 months
|
Respiratory Rate (RR)
Time Frame: 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.
|
up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johannes Bickenbach, Dr., University Hospital RWTH Aachen
Publications and helpful links
General Publications
- Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Borel JC, Pelletier J, Taleux N, Briault A, Arnol N, Pison C, Tamisier R, Timsit JF, Pepin JL. Parameters recorded by software of non-invasive ventilators predict COPD exacerbation: a proof-of-concept study. Thorax. 2015 Mar;70(3):284-5. doi: 10.1136/thoraxjnl-2014-206569. Epub 2015 Jan 12.
- Zilberberg MD, de Wit M, Pirone JR, Shorr AF. Growth in adult prolonged acute mechanical ventilation: implications for healthcare delivery. Crit Care Med. 2008 May;36(5):1451-5. doi: 10.1097/CCM.0b013e3181691a49.
- Lilly CM, Zuckerman IH, Badawi O, Riker RR. Benchmark data from more than 240,000 adults that reflect the current practice of critical care in the United States. Chest. 2011 Nov;140(5):1232-1242. doi: 10.1378/chest.11-0718. Epub 2011 Aug 25.
- Leidy NK, Wilcox TK, Jones PW, Murray L, Winnette R, Howard K, Petrillo J, Powers J, Sethi S; EXACT-PRO Study Group. Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure. Value Health. 2010 Dec;13(8):965-75. doi: 10.1111/j.1524-4733.2010.00772.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on Astral 150 ventilator
-
Centre d'Investigation Clinique et Technologique...ResMedCompleted
-
Centre d'Investigation Clinique et Technologique...CompletedRespiratory Failure | Neuromuscular DisorderFrance
-
University of Lausanne HospitalsCompletedRespiratoy Failure Requiring NIV TreatmentSwitzerland
-
ResMedCompletedRespiratory Failure | Respiratory Insufficiency | Upper Airway ObstructionUnited States
-
University of ThessalyUniversity of LausanneActive, not recruitingStroke Ischemic | Stroke Acute | Posterior Circulation Brain InfarctionGreece, Switzerland
-
Federal University of UberlandiaCompletedCoronary Artery Bypass
-
Mackay Memorial HospitalWithdrawn
-
University of MalayaNot yet recruitingARDS | Ventilator-Induced Lung Injury | Mechanical Ventilation Complication | Ventilator Lung
-
Eunhee ChunEnrolling by invitationVentilators, MechanicalKorea, Republic of
-
Medical University of ViennaCompletedRespiratory Tract Diseases | Lung Diseases | Extracorporeal Membrane Oxygenation | Respiratory Distress Syndrome | Acute Lung Injury | ARDS | Lung Injury, AcuteAustria