COPD Exacerbations

NCT02798575 | Terminated

• 1 other identifier: 16-025
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; invasive ventilation; exacerbation; home care; mechanical ventilation; unsuccessful weaning; ventilatory parameters

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 months

Secondary Outcomes (7)

• EXACT Pro Questionnaire

  up to 12 months

• Arterial blood gas (ABG)

  baseline, month 3, month 6 and month 12

• Evaluation of demographic data

  baseline, month 3, month 6 and month 12

• Daily usage of ventilator (in hours)

  up to 12 months

• Tidal volume

  up to 12 months

Interventions

Astral 150 ventilator DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD who are in need for invasive mechanical ventilation following unsuccessful weaning.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (5)

• 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.

  PMID: 25582449 BACKGROUND

• 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.

  PMID: 18434911 BACKGROUND

• 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.

  PMID: 21868469 BACKGROUND

• 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.

  PMID: 17470624 BACKGROUND

• 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.

  PMID: 20659270 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples for arterial blood gas analyses

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Bickenbach, Dr.

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)