- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942797
NRS 2002 as a Predictor of Prognosis in COPD With Respiratory Failure
December 18, 2019 updated by: Lu Xing, West China Hospital
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
520
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
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Hospital
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with chronic obstructive pulmonary disease with respiratory failure during April 2017 to March 2019 at West China Hospital.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
---|
NRS 2002 score ≥ 3
|
NRS 2002 score < 3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of Demographics (age, sex)
Time Frame: up to 2 years
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2017
Primary Completion (Actual)
March 22, 2019
Study Completion (Actual)
March 22, 2019
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 21, 2016
First Posted (Estimate)
October 24, 2016
Study Record Updates
Last Update Posted (Actual)
December 19, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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