Pulmonary Disease, Chronic ObstructiveNCT02942797
NRS 2002 as a Predictor of Prognosis in COPD With Respiratory Failure
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by West China Hospital at 1 site in China.
Trial summary
This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 22 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with chronic obstructive pulmonary disease with respiratory failure during April 2017 to March 2019 at West China Hospital.
Who may be able to join
- Newly diagnosis of COPD at West China Hospital during April 2017 to March 2019
- Partial pressure of O2 (PaO2) < 60 mmHg and/or partial pressure of CO2 (PaCO2) >50 mmHg
- Age ≥ 18 years
- Respiratory rates > 23 bpm
Who cannot join
- Pregnancy or during lactation
- Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
- Refused to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Risk Screening 2002 Should be Used to Predict Prognostic Outcomes in Chronic Obstructive Pulmonary Disease With Respiratory Failure
This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. The following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis predictor in COPD patients with respiratory failure.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NRS 2002 score ≥ 3 | Not described | |
| NRS 2002 score < 3 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of mortality
Measured: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of 30-day readmission after discharge
Measured: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of length of stay
Measured: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of complications
Measured: up to 2 years
Secondary outcomes (1)
Collection of Demographics (age, sex)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Apr 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Xing, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942797
- Sponsor's protocol ID
- COPD-002
- Status last verified
- Dec 2019
- First submitted
- 11 Oct 2016
- Last updated
- 19 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Risk Screening 2002 Should be Used to Predict Prognostic Outcomes in Chronic Obstructive Pulmonary Disease With Respiratory Failure
- ClinicalTrials.gov ID
- NCT02942797
- Acronym / sponsor ID
- COPD-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 24 Oct 2016 (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.
This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. The following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis predictor in COPD patients with respiratory failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRS 2002 score ≥ 3 | – | – |
| NRS 2002 score < 3 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic obstructive pulmonary disease with respiratory failure during April 2017 to March 2019 at West China Hospital.
Key inclusion criteria (4 listed)
- Newly diagnosis of COPD at West China Hospital during April 2017 to March 2019
- Partial pressure of O2 (PaO2) < 60 mmHg and/or partial pressure of CO2 (PaCO2) >50 mmHg
- Age ≥ 18 years
- Respiratory rates > 23 bpm
Key exclusion criteria (3 listed)
- Pregnancy or during lactation
- Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
- Refused to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of mortality
Time frame: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of 30-day readmission after discharge
Time frame: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of length of stay
Time frame: up to 2 years
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of complications
Time frame: up to 2 years
1 secondary outcome
Collection of Demographics (age, sex)
Time frame: up to 2 years
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 19 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by West China Hospital at 1 site in China.
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 4 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 19 Dec 2019. 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 China. 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?
Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of mortality (time frame: up to 2 years). The study lists 4 primary outcomes in all. 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 19 Dec 2019.