Clinical trial NCT05370664: Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Keywords: NIVO, DECAF, HACOR
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 203
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients enrolled in the study will be subjected to the following:

A- Careful History Taking and clinical examination.

B- Laboratory investigations which include :

I. Complete blood count. II. Arterial blood gas. III. Liver \& kidney function tests. IV. Blood sugar level \& serum electrolytes. V. Serum granulocyte colony-stimulating factor ( GM-CSF)

C- Severity of illness assessed by:

I. NIVO Score ( Non-invasive outcomes score )

II. DECAF Score

III. HACOR Score

IV. ( Acute physiology and chronic health evaluation ) APACHE IV Score. 200 patients (100 females, 100 males) with acute exacerbation of COPD will be admitted to the RICU will be observed as regards temperature, blood pressure, respiratory rate, pulse, oxygen saturation, and arterial blood gas will be obtained on NIV.

colony-stimulating factor will also be assessed on the first day of admission and after weaning from NIV.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality rate among COPD patients hospitalized due to acute exacerbation.
timeFrame: 28 days from admissiom
measure: Early prediction of NIV failure.
timeFrame: 48 hours from ICU admission
measure: Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.
timeFrame: baseline
Secondary outcomes:
measure: Assisted ventilation days.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.
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.
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):2004042. doi: 10.1183/13993003.04042-2020. Print 2021 Aug.
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.