NCT03011853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

10.9 years

First QC Date

November 20, 2016

Last Update Submit

February 20, 2020

Conditions

Chronic Obstructive Airways Disease ExacerbatedCritical Care

Outcome Measures

Primary Outcomes (1)

  • Six month survival

    180 days beginning with the day of admission to ICU

    180 days

Secondary Outcomes (2)

  • One year survival

    365 days

  • ICU length of stay

    up to 180 days

Study Arms (3)

Non-invasive only

Non-invasive ventilation as first and only respiratory support

Procedure: Non-invasive and/or invasive mechanical ventilation

Invasive

Invasive ventilation with intubation as first respiratory support

Procedure: Non-invasive and/or invasive mechanical ventilation

NIV+Inv

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

Procedure: Non-invasive and/or invasive mechanical ventilation

Interventions

Non-invasive and/or invasive mechanical ventilationPROCEDURE

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

InvasiveNIV+InvNon-invasive only

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Principal diagnosis of ICU stay: Acute on Chronic Obstructive Pulmonary Disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Västerviks sjukhus

Västervik, SE 59333, Sweden

Location

Study Officials

  • Sten M Walther, MD PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2016

First Posted

January 5, 2017

Study Start

January 1, 2008

Primary Completion

December 1, 2018

Study Completion

December 30, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)