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

NCT ID: NCT03011853

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2019-12-30

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.

Conditions

Chronic Obstructive Airways Disease Exacerbated; Critical Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-invasive only

Non-invasive ventilation as first and only respiratory support

Non-invasive and/or invasive mechanical ventilation

Intervention Type: PROCEDURE

Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU

Invasive

Invasive ventilation with intubation as first respiratory support

Non-invasive and/or invasive mechanical ventilation

Intervention Type: PROCEDURE

Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU

NIV+Inv

Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation

Non-invasive and/or invasive mechanical ventilation

Intervention Type: PROCEDURE

Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU

Interventions

Non-invasive and/or invasive mechanical ventilation

Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Intensive Care Registry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sten M Walther, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Västerviks sjukhus

Västervik, , Sweden

Countries

Sweden

Other Identifiers

NIV4COPD

Identifier Type: -

Identifier Source: org_study_id