Chronic Obstructive Airways Disease ExacerbatedNCT03011853
Survival After Failed First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Airways Disease Exacerbated and Critical Care, run by Swedish Intensive Care Registry at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Obstructive Airways Disease Exacerbated, Critical Care
- What is being tested?
- Non-invasive and/or invasive mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 7,900 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to 30 Dec 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients admitted to ICUs that are members of the Swedish Intensive Care Registry and participate in data collection and audit.
Who may be able to join
- Principal diagnosis of ICU stay: Acute on Chronic Obstructive Pulmonary Disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Non-invasive and/or invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive and/or invasive mechanical ventilationProcedure or surgery
Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive only | Non-invasive ventilation as first and only respiratory support Receives: Procedure: Non-invasive and/or invasive mechanical ventilation | |
| Invasive | Invasive ventilation with intubation as first respiratory support Receives: Procedure: Non-invasive and/or invasive mechanical ventilation | |
| NIV+Inv | Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation Receives: Procedure: Non-invasive and/or invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six month survival
180 days beginning with the day of admission to ICU
Measured: 180 days
Secondary outcomes (2)
One year survival
365 days beginning with the day of admission to ICU
Measured: 365 days
ICU length of stay
From time of admission to time of discharge or death, assessed up to 180 days
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2008
- Primary completionDec 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airways Disease ExacerbatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,900 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Swedish Intensive Care Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten M Walther, MD PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011853
- Sponsor's protocol ID
- NIV4COPD
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2016
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03011853
- Acronym / sponsor ID
- NIV4COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,900 participants (actual)
- Lead sponsor
- Swedish Intensive Care RegistryUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-invasive only | – | Procedure: Non-invasive and/or invasive mechanical ventilationNon-invasive ventilation as first and only respiratory support |
| Invasive | – | Procedure: Non-invasive and/or invasive mechanical ventilationInvasive ventilation with intubation as first respiratory support |
| NIV+Inv | – | Procedure: Non-invasive and/or invasive mechanical ventilationNon-invasive ventilation as first respiratory support followed by invasive ventilation with intubation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients admitted to ICUs that are members of the Swedish Intensive Care Registry and participate in data collection and audit.
Key inclusion criteria (1 listed)
- Principal diagnosis of ICU stay: Acute on Chronic Obstructive Pulmonary Disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive and/or invasive mechanical ventilationUse of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU | Procedure or surgery | Invasive, NIV+Inv, Non-invasive only |
Primary outcome
Six month survival
Time frame: 180 days
180 days beginning with the day of admission to ICU
2 secondary outcomes
One year survival
Time frame: 365 days
ICU length of stay
Time frame: up to 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten M Walther, MD PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Airways Disease Exacerbated and Critical Care, run by Swedish Intensive Care Registry at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six month survival (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.