Survival After Failed First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Observational cohort study of mid-to-long term survival of patients with acute on chronic obstructive pulmonary disease, analyzed per type of ventilation support provided during first 24 hours in intensive care.

Detailed Description
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Registry setting and procedures: The Swedish Intensive Care Registry (SIR) collects a comprehensive dataset of patient characteristics, intensive care procedures and outcomes using detailed guidelines. Continuous data are collected as raw data, validated locally and transferred electronically to the registry for central validation (confirmed to be within prespecified limits and inconsistencies and illogical entries identified). If necessary, data are returned for correction and revalidation before being accepted and added to the master database. Study participants: Patients with COPD as the principal diagnosis during their ICU stay were included in the study cohort. When patients had multiple admissions during the study period due to COPD the last admission only was included. Patients were excluded when nursing workload scores indicated active ventilation support during the first 24 hours but information on type of support (non-invasive or invasive ventilation) was lacking. Participants with missing vital status were also excluded from analysis. Patients were grouped according to the mode of the first-line ventilation support that was given during the initial 24 hours in ICU. The Standard therapy group did not receive any active ventilation support, the NIV only group received non-invasive ventilation support only, the NIV + Invasive mechanical ventilation (IMV) group received NIV followed by intubation and invasive ventilation support and, the IMV group were intubated and received invasive ventilation support without any preceding NIV trial.

Official Title
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Survival After Failure of First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease: a Cohort Study of Intensive Care Patients.

Conditions
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Chronic Obstructive Airways Disease Exacerbated, Critical Care

Intervention / Treatment
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* Procedure: Non-invasive and/or invasive mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Principal diagnosis of ICU stay: Acute on Chronic Obstructive Pulmonary Disease Exclusion Criteria: Multiple admissions of patients during study period: every admission but the last one is excluded. Conflicting data on ventilation support Vital status missing at 6 months

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-invasive only<br>Non-invasive ventilation as first and only respiratory support | Procedure: Non-invasive and/or invasive mechanical ventilation<br>* Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU<br>|
| Invasive<br>Invasive ventilation with intubation as first respiratory support | Procedure: Non-invasive and/or invasive mechanical ventilation<br>* Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU<br>|
| NIV+Inv<br>Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation | Procedure: Non-invasive and/or invasive mechanical ventilation<br>* Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six month survival | 180 days beginning with the day of admission to ICU | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One year survival | 365 days beginning with the day of admission to ICU | 365 days | 
| ICU length of stay | From time of admission to time of discharge or death, assessed up to 180 days | up to 180 days |