Non Invasive Ventilation in COPD: Predicting outcome in hospital and assessing quality of life over one year
| ISRCTN | ISRCTN22921168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22921168 |
| Secondary identifying numbers | V2.3 |
- Submission date
- 09/05/2016
- Registration date
- 04/07/2016
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. COPD is frequently complicated by episodes of sudden worsening of respiratory symptoms, termed ‘exacerbations’. Sometimes during an exacerbation waste gases rise to a dangerous level. In this setting additional breathing support may be required. This ‘assisted ventilation’can be in the form of a tube placed directly into the patient’s lungs or much more commonly in the form of a tight fitting facial mask. This technique is called non-invasive ventilation (NIV) and can be lifesaving. Determining which patients should receive NIV is a complex decision that requires an assessment of an individual’s chances of survival should NIV be provided. However even specialist clinicians are overly pessimistic about the results of NIV treatment, which may lead to patients being inappropriately denied treatment. A simple, reliable tool to accurately identify patients likely to benefit and enhance clinical decision making has tremendous potential to further increase appropriate use of NIV. The study team has developed a score (tool) to predict the chance of successful treatment if NIV is started. For this score to be used in day to day practice it needs to be tested to ensure it works as expected. Therefore data will be collected about the health of a group of patients who experience assisted ventilation over a year. The aim of this study is to assess whether this tool is able to predict the outcome of assisted ventilation. In a second part of the study, a group of patients that have previously received assisted ventilation will be followed up over one year and data about their quality of life and the impact of COPD on their day to day activities will be collected. This data will allow clinicians to better understand what a patient experiences after ventilation. From this information particular markers of poor quality of life may be identified.
Who can participate?
Adults aged 35 and over with COPD who smoke a pack of cigarettes a day for 10 years and need treatment with a breathing machine.
What does the study involve?
In the first part of the study, information about patient’s health is collected by their usual care team over the course of one year and stored in a database. The tool is then applied to the data in order to find out if it would have accurately predicted the outcome of the patient, had the tool been applied to the patient at the time that they received ventilation. In the second part of the study, at baseline (immediately prior to discharge) and then again after three, six and twelve months, patients complete a number of questionnaires about their state of health as well as simple physical test such as their oxygen levels and weight, in order to assess their quality of life, the impact of COPD on their lives and whether they would wish to have ventilation again in the future should the need arise.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants taking part in this study.
Where is the study run from?
1. North Tyneside General Hospital (UK)
2. Guy's Hospital, London (UK)
3. St Thomas' Hospital, London (UK)
4. Queen's Medical Centre, Nottingham (UK)
5. St James's University Hospital, Leeds (UK)
6. Queen Elizabeth Hospital, Gateshead (UK)
7. South Tyneside General Hospital, South Shields (UK)
8.Musgrove Hospital, Taunton (UK)
9. Derriford Hospital, Plymouth (UK)
10. Prince Philip Hospital, Llanelli (UK)
11. John Radcliffe Hospital, Oxford (UK)
12.Churchill Hospital, Oxford (UK)
When is the study starting and how long is it expected to run for?
May 2015 to November 2020
Who is funding the study?
1. Philips Respironics (UK)
2. Pfizer OpenAir (UK)
Who is the main contact?
1. Ms Victoria Ferguson (public)
2. Dr Tom Hartley (scientific)
Contact information
Public
Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
Scientific
Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
Study information
| Study design | Cross-sectional observation study with longitudinal follow up |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Validation of a novel scoring system to predict inpatient mortality in exacerbations of Chronic Obstructive Pulmonary Disease requiring assisted ventilation with supplementary longitudinal assessment of quality of life and other patient-centred outcomes over one year |
| Study acronym | NIVO |
| Study hypothesis | There are no existing tools in use routinely in clinical practice to predict outcomes following an exacerbation of chronic obstructive pulmonary disease (COPD) requiring assisted ventilation. We are developing a tool to predict in-hospital mortality (ISRCTN16977236). Among patients who survive to discharge, little is known about patient-centred outcomes including quality of life, functional status and survival; a better understanding of such outcomes would help inform appropriate future care planning, including palliative care. The principal aims of this study are: 1. To prospectively validate the tool to predict in-hospital mortality in multiple centres 2. Among patients who survive to discharge, to identify predictors of six month mortality and perform longitudinal assessment of patient-centred outcomes including quality of life and functional status. Patients' views regarding their recent experience of assisted ventilation and willingness to undergo such treatment again will also be captured. |
| Ethics approval(s) | North East - Tyne & Wear South Research Ethics Committee, 11/07/2016, ref: 16/NE/0213, IRAS project ID: 206694 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Validation study Each patient meeting selection criteria has a dataset collected by their usual care team. This data comprises descriptive indices, the components of our derived tool and other comparative tools, other clinical indices and mortality and readmissions to one year. Anonymised data is entered onto a centralised database. Following completion performance of the tool will be assessed by AUROC curve analysis. Longitudinal study: At baseline (immediately prior to discharge), 3, 6 and 12 months questionnaires and physical tests (spirometry, weight, oxygen saturation) are measured in a face to face interview either in hospital or patient's home. In addition, at baseline and 3 months future ventilation questions are asked. Every month throughout the study (i.e. months 1-12) the patient complete the following questionnaires which will be given out and collected at researcher visits: COPD assessment test (CAT), extended medical research council dyspnoea score (eMRCD), Nottingham extended activity of daily living scale (NEADL), EQ-5D-5L and hospital anxiety and depression score (HADS). |
| Intervention type | Other |
| Primary outcome measure | Prediction of in-hospital mortality within the validation 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 | In the admitted population: 1. Comparison of the AUROC curves for both novel tools 2. Comparison of the AUROC curves for both novel tools to CAPS, APACHE II and Confalonieri risk chart Among patients surviving to discharge: 1. Mortality to 1 year by review of electronic record, contacting GP or review of patient notes 2. Readmission rates at 30, 90 and 365 days by review of electronic record, contacting GP, review of patient notes 3. Comparison of mortality and clinically significant change in quality of life in patients with, and without pre-defined characteristics: 3.1. Late failure of NIV (recurrent respiratory acidaemia, despite on-going ventilatory support; in-patient mortality will also be captured). 3.2. Persistent hypercapnia. 3.3. Long-term oxygen therapy. 3.4. Long-term ventilation on discharge. 3.5. Eosinopenia (<0.05 109/L) at discharge 4. Longitudinal changes in patient reported outcomes (CAT, eQ-5D-5L, NEADL, HADS) post discharge, quantified by calculating: mean change (relative to the minimum clinically important difference (MCID)); duration maintained above baseline and time taken to reach peak 5. Predictors of a) 6 month mortality and b) poor baseline QoL with a subsequent clinically significant deterioration (poor recovery) 6. Relation between clinically significant anxiety and depression on discharge and: survival, QoL, functional status and readmission rate 7. Examination of patient willingness to undergo ventilation again in the future by direct questioning at baseline and 3 months |
| Overall study start date | 05/05/2015 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 425 (minimum) |
| Total final enrolment | 844 |
| Participant inclusion criteria | 1. Age 35 years or older 2. Smoking history greater than or equal to 10 pack years (1 pack per day for 10 years) 3. Obstructive spirometry (FEV1/FVC < 0.7) 4. Acute exacerbation of COPD (AECOPD) primary diagnosis 5. Respiratory acidosis treated with NIV or IPPV (arterial blood gas pH <7.35, pCO2 > 6.5) |
| Participant exclusion criteria | 1. Previous inclusion in the study 2. Other illness likely to limit survival to less than 1 year |
| Recruitment start date | 18/10/2016 |
| Recruitment end date | 28/02/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
North Shields
NE29 8NH
United Kingdom
London
SE1 9RT
United Kingdom
SE1 7EH
LS9 7TF
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Leeds
LS9 7TF
United Kingdom
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
South Shields
NE34 0PL
United Kingdom
Taunton
TA1 5DA
United Kingdom
Crownhill
PL6 8DH
United Kingdom
Llanelli
SA14 8QF
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
England
United Kingdom
"ROR" |
https://ror.org/01gfeyd95 |
|---|
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 30/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. The findings will be disseminated to a broad regional, national and international audience, including respiratory specialists, general physicians and intensive care physicians, through presentations at local, national and international conferences, and publication in high ranking, peer-reviewed, journals. Open access publication fees are included in our application. 2. Locally, we will keep patients, carers, primary and secondary care clinicians, healthcare managers, commissioners and neighbouring healthcare providers informed by publications in existing newsletters and presentations at local and regional meetings, conducted within both NHS organisations and the University. Through established links with the British Lung Foundation (BLF), we will seek to disseminate the results of the study through BLF electronic and published media. We will establish a patient/public group of service users and encourage them to publish the results from the perspective of patients and carers, facilitated by the research team and the BLF. 3. The research team and co-applicants include members (and the chair) of the UK NIV Research Network. We will keep the network and British Thoracic Society COPD Speciality Advisory Group (SAG) and clinical guideline groups informed about the progress and outcome of the study. 4. We will liaise with NHS Improving Quality; the scores developed could be implemented as part of a national service improvement project. A previous study conducted by our group describing the DECAF prognostic score was published in Thorax, awarded several international prizes recognising its importance and impact, and its use in clinical practice has been recommended by the recent National UK COPD Audit report. We expect similar success in the dissemination and clinical implementation of the results of the proposed study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Stephen Bourke at Stephen.bourke@nhct.nhs.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at American Thoracic Society International Conference | 01/05/2020 | 12/05/2020 | No | No |
| Abstract results | results presented at British Thoracic Society Winter Meeting | 01/12/2019 | 12/05/2020 | No | No |
| Results article | 12/08/2021 | 11/01/2022 | Yes | No | |
| Protocol file | version 2.4 | 19/08/2016 | 17/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
17/08/2022: Protocol file uploaded.
11/01/2022: Publication reference added.
23/11/2020: The total final enrolment was changed from 733 to 844.
12/05/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/03/2019 to 30/11/2020.
2. The intention to publish date has been changed from 30/11/2019 to 30/03/2021.
3. The total final enrolment number has been added.
4. Publication references have been added.
5. The plain English summary has been updated to reflect the changes above.
12/03/2018: The following changes were made:
1. Recruitment end date was updated from 04/02/2018 to 28/02/2018
2. Overall trial end date was updated from 04/02/2019 to 30/03/2019
3. Intention to publish date was updated from 01/08/2019 to 30/11/2019
4. Queen Elizabeth Hospital, South Tyneside General Hospital, Musgrove Hospital, Derriford Hospital, Prince Philip Hospital, John Radcliffe Hospital and Churchill Hospital were added as trial participating centres.
04/09/2017: Ethics approval information has been updated.
04/11/2016: The recruitment start date has been updated from 01/08/2016 to 18/10/2016.
