Clinical trial NCT03011853: Survival After Failed First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease
Official title: Survival After Failure of First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease: a Cohort Study of Intensive Care Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Airways Disease Exacerbated
Critical Care
Lead sponsor: Swedish Intensive Care Registry
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 7900
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to ICUs that are members of the Swedish Intensive Care Registry and participate in data collection and audit.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six month survival
timeFrame: 180 days
Secondary outcomes:
measure: One year survival
timeFrame: 365 days
measure: ICU length of stay
timeFrame: up to 180 days
Other outcomes:
Locations:
city: Vastervik
country: Sweden
facility: Västerviks sjukhus
Study officials:
affiliation: Linkoeping University
name: Sten M Walther, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: