NCT02942797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
13 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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

October 11, 2016

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Predictive value of NRS 2002 in identifying COPD patients with respiratory failure who will have poor prognostic outcomes, in terms of mortality

    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

    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

    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

    up to 2 years

Secondary Outcomes (1)

  • Collection of Demographics (age, sex)

    up to 2 years

Study Arms (2)

NRS 2002 score ≥ 3

NRS 2002 score < 3

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 April 2017 to March 2019 at West China Hospital.

You may qualify if:

  • 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

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
  • Refused to participate in this study

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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Master Degree

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 24, 2016

Study Start

April 1, 2017

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations