COPDNCT02798575
COPD Exacerbations
An observational study of COPD, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Astral 150 ventilator
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD who are in need for invasive mechanical ventilation following unsuccessful weaning.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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
- Conditions
- COPD
- Being tested
- Astral 150 ventilator
- Keywords
- COPD, invasive ventilation, exacerbation, home care, mechanical ventilation, unsuccessful weaning, ventilatory parameters
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astral 150 ventilatorDevice
Patients indicative for invasive ventilation will receive the Astral 150 ventilator at the weaning station of the hospital. The ventilator will be set by the physician. Afterwards patients will be transferred into home care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of an exacerbation of COPD
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.
Measured: up to 12 months
Secondary outcomes (7)
EXACT Pro Questionnaire
The questionnaire will be performed weekly by patients or legal representative in order to evaluate exacerbations and respiratory symptoms in clinical studies of COPD.
Measured: up to 12 months
Arterial blood gas (ABG)
Blood samples for arterial blood gas analysis (ABG) will be performed at baseline, month 3, month 6 and month 12.
Measured: baseline, month 3, month 6 and month 12
Evaluation of demographic data
Demographic data will be recorded and evaluated at baseline, follow up at month 3, month 6 and month 12.
Measured: baseline, month 3, month 6 and month 12
Daily usage of ventilator (in hours)
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.
Measured: up to 12 months
Tidal volume
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.
Measured: up to 12 months
%Trigg cycled breaths
%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.
Measured: up to 12 months
Respiratory Rate (RR)
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Bickenbach, Dr., Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798575
- Sponsor's protocol ID
- 16-025
- Status last verified
- Sep 2018
- First submitted
- 3 Jun 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 25582449Zilberberg 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.
PubMed 18434911Lilly 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.
PubMed 21868469Boles 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.
PubMed 17470624Leidy 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.
PubMed 20659270
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Chronic Obstructive Pulmonary Disease (COPD) Exacerbations and Need for Hospitalization With Software Analysis of Ventilators for Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02798575
- Acronym / sponsor ID
- 16-025
- Conditions
- COPD
- Keywords
- COPD, invasive ventilation, exacerbation, home care, mechanical ventilation, unsuccessful weaning, ventilatory parameters
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD who are in need for invasive mechanical ventilation following unsuccessful weaning.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astral 150 ventilatorPatients indicative for invasive ventilation will receive the Astral 150 ventilator at the weaning station of the hospital. The ventilator will be set by the physician. Afterwards patients will be transferred into home care. | Device | – |
Primary outcome
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.
7 secondary outcomes
EXACT Pro Questionnaire
Time frame: up to 12 months
Arterial blood gas (ABG)
Time frame: baseline, month 3, month 6 and month 12
Evaluation of demographic data
Time frame: baseline, month 3, month 6 and month 12
Daily usage of ventilator (in hours)
Time frame: up to 12 months
Tidal volume
Time frame: up to 12 months
%Trigg cycled breaths
Time frame: up to 12 months
Respiratory Rate (RR)
Time frame: up to 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 25582449Borel 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.
- Background: PubMed 18434911Zilberberg 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.
- Background: PubMed 21868469Lilly 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.
- Background: PubMed 17470624Boles 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.
- Background: PubMed 20659270Leidy 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Bickenbach, Dr. principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of an exacerbation of COPD (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798575, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.