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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN22921168
Enrollment
425
Registered
2016-07-04
Start date
2016-10-18
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 a

Sponsors

Northumbria Healthcare NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 6.5)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom, Wales

Contacts

Public ContactVictoria Ferguson

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026