Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05370664

Enrollment

203

Registered

2022-05-11

Start date

2022-07-31

Completion date

2025-04-30

Last updated

2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

NIVO, DECAF, HACOR

Brief summary

* Assess predictors of mortality in COPD exacerbation between men and women. * Evaluate the clinical outcomes in acute exacerbation of COPD in women. * Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD. * Compare these new scoring system with the most widely used APACHE IV. * Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH \< 7.35 and PaCO2 \> 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation

Exclusion criteria

* Requirement for emergency intubation. * Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6) * Age \< 35 years.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.	baseline	Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD
Early prediction of NIV failure.	48 hours from ICU admission	Using NIVO score for Acute exacerbaion of COPD Non-invasive ventilation outcomes score is considered to be Low risk ( 0-2) Moderate risk (3-4) High risk (5-6) Very high risk ( 7-9)
Mortality rate among COPD patients hospitalized due to acute exacerbation.	28 days from admissiom	Assessment of mortality with different scoring systems in acute exacerbation of COPD

Secondary

Measure	Time frame	Description
Assisted ventilation days.	Baseline	Estimating the number of days required for either non-invasive or invasive mechanical ventilation

Contacts

Primary ContactKhaled Essmat Hussien, MSSH

khaledessmat90@gmail.com01003382727

Backup ContactSahar Refaat Mahmoud, MD

farida62014@gmail.com01002866364

Outcome results