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

S

Swedish Intensive Care Registry

Status

Completed

Conditions

Critical Care
Chronic Obstructive Airways Disease Exacerbated

Treatments

Procedure: Non-invasive and/or invasive mechanical ventilation

Study type

Observational

Funder types

Other

Identifiers

NCT03011853
NIV4COPD

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,900 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

7,900 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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