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Completed

NCT Number: NCT03011853

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Västerviks sjukhus

Västervik, SE 59333, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive and/or invasive mechanical ventilation

Procedure

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

Primary outcomes

  1. Six month survival

    Time frame: 180 days

    180 days beginning with the day of admission to ICU

Secondary outcomes

  1. One year survival

    Time frame: 365 days

    365 days beginning with the day of admission to ICU

  2. ICU length of stay

    Time frame: up to 180 days

    From time of admission to time of discharge or death, assessed up to 180 days

Sponsors and collaborators

Lead sponsor

Swedish Intensive Care Registry

Other

Registry information

Official study title

Survival After Failure of First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease: a Cohort Study of Intensive Care Patients.

Important dates

Study start
2008
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2017
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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