NCT02942784

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2017

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

October 10, 2016

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Predictive value of nutritional assessment methods in identifying COPD patients with respiratory failure who will have poor prognosis, in terms of in-hospital death

    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

    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

    up to 27 months

Secondary Outcomes (4)

  • Collection of Demographics (age, sex, marriage)

    up to 27 months

  • Number of participants with in-hospital death

    up to 27 months

  • Number of participants with 1-year death after discharge

    up to 27 months

  • Number of participants with 30-day readmission after discharge

    up to 27 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or during lactation
  • Ventilatory dysfunction due to neuromuscular disorders, acute and chronic thromboembolic disease, severe illness in other systems
  • Incomplete medical profiles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Master Degree

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 24, 2016

Study Start

April 1, 2017

Primary Completion

May 12, 2017

Study Completion

May 12, 2017

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations