Condition category
Respiratory
Date applied
23/06/2015
Date assigned
07/08/2015
Last edited
07/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COPD is a common chronic lung disease. Acute exacerbations (AECOPD) are often triggered by infection and are the second commonest reason for hospital admission in the UK. Severe exacerbations resulting in respiratory failure are associated with high mortality (death), which is reduced by 2-3 times by the use of non-invasive ventilation (NIV). Unfortunately the national COPD audit showed that of 26% of patients who met the criteria for ventilation, only 12% received it. In part, this reflects difficulty in accurately predicting outcome following NIV and widespread prognostic pessimism. Decisions about suitability for ventilation should be informed by reliable estimates of the patients’ chance of surviving the acute event and subsequent outcomes. Clinicians are unduly pessimistic as shown in a recent study (CAOS); actual six-month survival was four-fold better than predicted in some patients. Most survivors would choose ventilation again. Prognostic tools outperform clinicians’ estimates in most settings. We will assess outcomes following AECOPD requiring ventilation and develop simple prognostic tools assessing in-hospital mortality.

Who can participate?
The study is retrospective (ie. looking at events that have already occurred). It will include all those admitted consecutively to our trust with AECOPD requiring assisted ventilation from December 2008 onwards until at least 425 patients have been identified and included.

What does the study involve?
The patients included in the study are not exposed to any test or treatment only collection of data from case records. Any analysis or publication of data is anonymised . As such individual patient consent is not being sought for inclusion in the study. This approach has been approved by both patient focus group and a research ethics committee.

What are the possible benefits and risks of participating?
The successful development of a predictive tool will, we hope, lead to better decision in a life threatening situation. Nihilism will be challenged and more patients will consequently receive non-invasive ventilation. There are no perceived risks of participation.

Where is the study run from?
North Tyneside General Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2014 to May 2016.

Who is funding the study?
Northumbria Healthcare NHS Foundation Trust.

Who is the main contact?
Dr Tom Hartley
tomhartley@nhct.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Tom Hartley

ORCID ID

Contact details

Research and Development
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
04448118111
tom.hartley@nhct.nhs.uk

Type

Scientific

Additional contact

Dr Stephen Bourke

ORCID ID

Contact details

North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol ref v4.1

Study information

Scientific title

Derivation of a novel scoring system to predict inpatient mortality in exacerbations of chronic obstructive pulmonary disease requiring assisted ventilation.

Acronym

Study hypothesis

Clinicians' estimate of survival and prognosis is poor and is consistently outperformed by predictive tools. In acute exacerbations of COPD (AECOPD) requiring assisted ventilation the CAOS study highlighted pronostic nihilism. The national COPD audit showed that 26% of patients developed respiratory acidaemia but only 12% were ventilated. No predictive tool is routinely used in clinical practice in this group. The use of non-invasive ventilation is widespread and often initiated by the non specialist. Developing a predictive tool to augment decision making will reduce nihilism and increase use of a treatment shown to save lives, allow better prognostic information to be shared with a patient leading to shared decision making and in a small number of patients highlight the importance of palliative care.

Ethics approval

NRES Committee North West - Liverpool Central 29/5/2015, ref: 15/NW/0389

Study design

Observational single centre study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Chronic obstructive pulmonary disease (COPD).

Intervention

Consecutive patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) requiring assisted ventilation will be identified. Indices including; socio-demographic data, biochemical, clinical data and functional status will be collected. Variables related to mortality on univariate analysis will be identified. Eligible variables will be entered into backward stepwise logistic regression, with in-hospital mortality as the dependant variable. To ensure that the final model can be easily applied at the bedside, the final number of variables will be reduced to the minimum required to maintain prediction of in-hospital mortality. Performance will be assessed by AUROC curve. Mortality and readmission rates will be compared in patients with and without predefined characteristics, namely: Late failure of NIV, persistent hypercapnia, long term oxygen, long term ventilation.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Prediction of in-hospital mortality within the derivation cohort, assessed by the area under the receiver operating characteristic (AUROC) curve for tools developed using:
1. Indices available on admission
2. All indices up to and including the time of deterioration

Secondary outcome measures

1. Comparison of the AUROC curves for both novel tools
2. Comparison of the AUROC curves for both novel tools to CAPS and APACHE II
3. 30 day, 90 day, 180 day and 1 year mortality
4. 30 and 90 day readmission rates
5. Comparison of outcomes in patients with, and without pre-defined characteristics:
5.1. Late failure of NIV (recurrent respiratory acidaemia, despite on-going ventilatory support)
5.2. Persistent hypercapnia
5.3. Long-term oxygen therapy
5.4. Long-term ventilation on discharge

Overall trial start date

01/05/2014

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 35 years.
2. Smoking history greater than or equal to 10 pack years.
3. Obstructive spirometry (FEV1/FVC < 0.7).
4. AECOPD primary diagnosis.
5. Respiratory acidosis treated with NIV or IPPV (arterial blood gas pH <7.35, pCO2 > 6.0).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

425

Participant exclusion criteria

1. Previous inclusion in the study
2. Other illness likely to limit survival to less than 1 year

Recruitment start date

01/07/2015

Recruitment end date

01/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane North Shields
NE29 8NH
United Kingdom

Trial participating centre

Wansbeck General Hopsital
Woodhorn Lane Ashington
NE63 9JJ
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

c/o Caroline Potts
Research and Development
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Research and Development Department, Northumbria Healthcare NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes