Non Invasive Ventilation in COPD: Predicting outcome in hospital and assessing quality of life over one year

• Register: ISRCTN
• Last refreshed on: 29 August 2022
• Main ID: ISRCTN22921168
• Date of registration: 04/07/2016
• Prospective Registration: Yes
• Primary sponsor: Northumbria Healthcare NHS Foundation Trust
• Public title: Non Invasive Ventilation in COPD: Predicting outcome in hospital and assessing quality of life over one year
• 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
• Date of first enrolment: 18/10/2016
• Target sample size: 425
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN22921168
• Study type: Observational
• Study design: Cross-sectional observation study with longitudinal follow up (Other)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom, Wales

Contacts

• Name: Tom Hartley

• Name: Victoria Ferguson

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic obstructive pulmonary disease (COPD)
Respiratory
Chronic obstructive pulmonary disease (COPD)

Intervention(s)

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).

Primary Outcome(s)

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(s)

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

Secondary ID(s)

V2.3

Source(s) of Monetary Support

Philips Respironics, Pfizer OpenAir

Ethics review

Status:
Approval date:
Contact:

North East - Tyne & Wear South Research Ethics Committee, 11/07/2016, ref: 16/NE/0213, IRAS project ID: 206694

Results

• Results available: Yes
• Date Completed: 30/11/2020