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

NCT ID: NCT05370664

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-31

Study Completion Date

2025-04-30

Brief Summary

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* 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.

Detailed Description

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Conditions

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COPD Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Female COPD

No interventions assigned to this group

Male COPD

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Essmat Hussien

Assistant Lecturer of chest diseases and tuberculosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Khaled Essmat Hussien, MSSH

Role: CONTACT

01003382727

Sahar Refaat Mahmoud, MD

Role: CONTACT

01002866364

References

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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.

Reference Type BACKGROUND
PMID: 33146552 (View on PubMed)

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):00836-2020. doi: 10.1183/23120541.00836-2020. eCollection 2021 Jul.

Reference Type BACKGROUND
PMID: 34350278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27816445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31565779 (View on PubMed)

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):2004042. doi: 10.1183/13993003.04042-2020. Print 2021 Aug.

Reference Type BACKGROUND
PMID: 33479109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22895999 (View on PubMed)

Other Identifiers

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Mortality outcome in COPD

Identifier Type: -

Identifier Source: org_study_id

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