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

Critical Care Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011853
• Other study ID #: NIV4COPD
• Status: Completed
• Start date: January 2008
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Swedish Intensive Care Registry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7900
• Est. completion date: December 30, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Airways Disease Exacerbated
• Critical Care
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Sweden	Västerviks sjukhus	Vastervik

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Intensive Care Registry

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six month survival	180 days beginning with the day of admission to ICU	180 days
Secondary	One year survival	365 days beginning with the day of admission to ICU	365 days
Secondary	ICU length of stay	From time of admission to time of discharge or death, assessed up to 180 days	up to 180 days