Assessment of Updated Evaluation Scores in Critically ILL COPD Patients Admitted to Assiut University Hospital

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of morbidity and mortality.Patients admitted to hospital present higher mortality rates.The investigators lack the specific tools that allow us to easily classify and establish the individual prognosis for each patient during their hospitalization.

Rational of the study:to identify the predictive factors for hospital mortality in critically ill patients admitted to hospital due to an episode of COPD exacerbation.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

Material and Methods:

A) sociodemographic variables:

Age, sex, marital status, occupation, pack\year.

B) clinical variables:

1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test (CAT ) while stable, previous to admittance.

3- Charlson comorbidity index and age adjusted model.

4- The APACHE II scale: the severity of the episode upon admittance, calculated using the APACHE II scale, using the worst value obtained in the first 24h after being admitted to hospital.

5- the Sequential Organ Failure Assessment (SOFA) scale.

6- Lab parameters: such as glucose, albumin and heamatocrit

7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse > 109 beats/min, age > 65 years.

8- Assessment of symptom of gastroesophageal reflux disease.

9-Glasgow scale score.

10-CURB 65 :"C" stands for "confused"; "U" stands for BUN greater than19 mg/dL; "R" stands for "respiration more than 30 breaths per minute""B" stands for blood pressure less than 90 mm Hg systolic or diastolic blood pressure 60 mm Hg or less; "65" stands ≥65 years.

11-CAUDA 70: C: Confusion, Acidosis (pH <7.35), Urea >7mmol/L, MRC Dyspnoea score >4, Albumin <35g/L, Age >70 years. One point was assigned to each variable present, giving a six point scoring system.

12-The COPD and Asthma Physiology Score.

13-The early warning score.

14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component were added so that the ADO index ranged from 0 to 10.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Nermeen Abdel Aleem; Phone Number: 01007174772; Email: nermeenabdelaleem@gmail.com
• Study Contact Backup: Name: Mohamed Metwally; Phone Number: 01223971614; Email: melhadi@yahoo.com

Study Locations

• Egypt
  • Assuit, Egypt
    • Recruiting
    • Chest Department-faculty of medicine-Assuit university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We include for study all patients critically ill hospitalized for COPD exacerbation during the study period.

Description

Inclusion Criteria:

• We include for study all patients critically ill hospitalized for COPD exacerbation during the study period

Exclusion Criteria:

• Patients who refuse to be admitted to hospital after having been properly informed, and their families as well, of the possible risks that they are assuming.
• Specific diagnosis: pulmonary edema, rib fractures, aspiration, pleural effusion, etc. upon admission.
• Other associated respiratory pathology that determines treatment: pulmonary fibrosis, kyphoscoliosis, neuromuscular pathology, upper airway obstruction, extensive tuberculosis sequelae.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the mortality of exacerbated patients based on APACHE II and SOFA score, respiratory rate upon admittance, age, pO2/ FiO2 in the first few hours of admittance.	Calculate mortality caused by AECOPD depend upon APACHE II and SOFA score	24 hours

Collaborators and Investigators

• Sponsor: Nermeen Aly Mahmoud Abdel Aleem

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: October 4, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 16022012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No