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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05370664
• Other study ID #: Mortality outcome in COPD
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: April 2025

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: Khaled Essmat Hussien, MSSH
• Phone: 01003382727
• Email: khaledessmat90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 203
• Est. completion date: April 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Chakrabarti A, Mar JS, Choy DF, Cao Y, Rathore N, Yang X, Tew GW, Li O, Woodruff PG, Brightling CE, Grimbaldeston M, Christenson SA, Bafadhel M, Rosenberger CM. High serum granulocyte-colony stimulating factor characterises neutrophilic COPD exacerbations associated with dysbiosis. ERJ Open Res. 2021 Aug 2;7(3). pii: 00836-2020. doi: 10.1183/23120541.00836-2020. eCollection 2021 Jul. — View Citation

Duan J, Wang S, Liu P, Han X, Tian Y, Gao F, Zhou J, Mou J, Qin Q, Yu J, Bai L, Zhou L, Zhang R. Early prediction of noninvasive ventilation failure in COPD patients: derivation, internal validation, and external validation of a simple risk score. Ann Intensive Care. 2019 Sep 30;9(1):108. doi: 10.1186/s13613-019-0585-9. — View Citation

Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ, Agusti AA, Vogelmeier CF. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2021 Jan 1;203(1):24-36. doi: 10.1164/rccm.202009-3533SO. Review. — View Citation

Hartley T, Lane ND, Steer J, Elliott MW, Sovani MP, Curtis HJ, Fuller ER, Murphy PB, Shrikrishna D, Lewis KE, Ward NR, Turnbull CD, Hart N, Bourke SC. The Noninvasive Ventilation Outcomes (NIVO) score: prediction of in-hospital mortality in exacerbations of COPD requiring assisted ventilation. Eur Respir J. 2021 Aug 12;58(2). pii: 2004042. doi: 10.1183/13993003.04042-2020. Print 2021 Aug. Erratum in: Eur Respir J. 2021 Nov 11;58(5):. — View Citation

Jenkins CR, Chapman KR, Donohue JF, Roche N, Tsiligianni I, Han MK. Improving the Management of COPD in Women. Chest. 2017 Mar;151(3):686-696. doi: 10.1016/j.chest.2016.10.031. Epub 2016 Nov 2. Review. — View Citation

Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate among COPD patients hospitalized due to acute exacerbation.	Assessment of mortality with different scoring systems in acute exacerbation of COPD	28 days from admissiom
Primary	Early prediction of NIV failure.	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)	48 hours from ICU admission
Primary	Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.	Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD	baseline
Secondary	Assisted ventilation days.	Estimating the number of days required for either non-invasive or invasive mechanical ventilation	Baseline