- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942784
A Comparison of Three Nutritional Assessment Methods Predicting Prognosis in COPD With Respiratory Failure
December 18, 2019 updated by: Lu Xing, West China Hospital
Prediction of Prognosis in Patients With Chronic Obstructive Pulmonary Disease With Respiratory Failure: A Comparison of Three Nutritional Assessment Methods
This is a retrospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during January 2014 to March 2016 by review of medical records.
The following variables will be retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2, nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic outcomes, and so on.
The purpose of this study is to compare the predictive power of three widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic outcomes in a cohort of COPD patients with respiratory failure.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
750
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 January 2014 to March 2016 at West China Hospital by review of medical records.
Description
Inclusion Criteria:
- Newly diagnosis of COPD at West China Hospital during January 2014 to March 2016
- 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
- Incomplete medical profiles
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of in-hospital death
Time Frame: up to 27 months
|
up to 27 months
|
Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 1-year death after discharge
Time Frame: up to 27 months
|
up to 27 months
|
Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of 30-day readmission after discharge
Time Frame: up to 27 months
|
up to 27 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of Demographics (age, sex, marriage)
Time Frame: up to 27 months
|
up to 27 months
|
Number of participants with in-hospital death
Time Frame: up to 27 months
|
up to 27 months
|
Number of participants with 1-year death after discharge
Time Frame: up to 27 months
|
up to 27 months
|
Number of participants with 30-day readmission after discharge
Time Frame: up to 27 months
|
up to 27 months
|
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)
May 12, 2017
Study Completion (Actual)
May 12, 2017
Study Registration Dates
First Submitted
October 10, 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-001
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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