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

Completed

• Conditions: Critical Care; Chronic Obstructive Airways Disease Exacerbated
• Interventions: Procedure: Non-invasive and/or invasive mechanical ventilation

• Registration Number: NCT03011853
• Lead Sponsor: Swedish Intensive Care Registry

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2018-12
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Invasive	Non-invasive and/or invasive mechanical ventilation	Invasive ventilation with intubation as first respiratory support
Non-invasive only	Non-invasive and/or invasive mechanical ventilation	Non-invasive ventilation as first and only respiratory support
NIV+Inv	Non-invasive and/or invasive mechanical ventilation	Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation

Primary Outcome Measures

Name	Time	Method
Six month survival	180 days	180 days beginning with the day of admission to ICU

Secondary Outcome Measures

Name	Time	Method
One year survival	365 days	365 days beginning with the day of admission to ICU
ICU length of stay	up to 180 days	From time of admission to time of discharge or death, assessed up to 180 days

Trial Locations

Locations (1)

Västerviks sjukhus; 🇸🇪 Vastervik, Sweden