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

February 20, 2020 updated by: Swedish Intensive Care Registry

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Vastervik, Sweden, SE 59333
        • Västerviks sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-invasive only
Non-invasive ventilation as first and only respiratory support
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
Invasive
Invasive ventilation with intubation as first respiratory support
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
NIV+Inv
Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Six month survival
Time Frame: 180 days
180 days beginning with the day of admission to ICU
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
One year survival
Time Frame: 365 days
365 days beginning with the day of admission to ICU
365 days
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
up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swedish Intensive Care Registry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sten M Walther, MD PhD, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIV4COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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