Chronic Obstructive Pulmonary DiseaseNCT05793697
Assessment Of Different Scores In Predicting Outcome In AECOPD Patients In Emergency Department
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University.
Trial summary
evaluate the value of different scores in predicting hospital mortality and Need for MV In patients presented to ED with AECOPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2023to 3 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient presented to ED with acute exacerbation of COPD no gender discrimination from 18 years to unlimit age
Who may be able to join
- All patient presented to ED with acute exacerbation of COPD.
Who cannot join
- Patient presented with acute insult affecting other system.
- Patient transferred to other centers.
- Inadequate data.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department
evaluate the value of different scores in predicting hospital mortality and Need for MV In patients presented to ED with AECOPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is one of the top three causes of death worldwide, and 90% of deaths occur in low- and middle-income countries.
Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is defined as an acute change in patient's dyspnea, cough, or sputum beyond normal variability that is sufficient to warrant a change in therapy. AECOPD has a negative effect on the quality of life, admission and readmission rates, and disease progression.
For these reasons, appropriate management of acute exacerbations is recommended by national and international organizations.
Identifying high-risk dying patients on hospital admission helps in triaging them to the required level of care.
The use of early warning scores in follow-up is recommended for the early detection of critically ill patients and the prediction of clinical deterioration. CURB65, BAP65, qSOFA , DECAF and NEWS, which mainly involve mental status, respiratory rate, oxygen saturations, pulse, blood pressure, age, BUN level, etc., can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the value of different scores in predicting hospital mortality
Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department as DECAF(dyspnea grade V according to eMRCD,esinopenia<0.05x10*9/L,consolidation,acidemia<7.30,atrial fibrillation)
1=mild,2_3=moderate,4_5=severe can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.
Measured: one year
Secondary outcomes (1)
Value of these scores in predicting need for MV.
Value of these scores in predicting need for MV in AECOPD patient in ER
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start3 May 2023 (estimated)
- Primary completion3 Jan 2024 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mostafa Saleh Hussein, Assiut University
- Investigators
- reham mo abdelmonem, MD, Study director, Assiut Uneversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793697
- Sponsor's protocol ID
- different scores in AECOPD
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: sharing the result of the study after completion
Publications
Redfern OC, Smith GB, Prytherch DR, Meredith P, Inada-Kim M, Schmidt PE. A Comparison of the Quick Sequential (Sepsis-Related) Organ Failure Assessment Score and the National Early Warning Score in Non-ICU Patients With/Without Infection. Crit Care Med. 2018 Dec;46(12):1923-1933. doi: 10.1097/CCM.0000000000003359.
PubMed 30130262
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department
- ClinicalTrials.gov ID
- NCT05793697
- Acronym / sponsor ID
- different scores in AECOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (estimated)
- Primary completion
- 3 Jan 2024 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluate the value of different scores in predicting hospital mortality and Need for MV In patients presented to ED with AECOPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is one of the top three causes of death worldwide, and 90% of deaths occur in low- and middle-income countries.
Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is defined as an acute change in patient's dyspnea, cough, or sputum beyond normal variability that is sufficient to warrant a change in therapy. AECOPD has a negative effect on the quality of life, admission and readmission rates, and disease progression.
For these reasons, appropriate management of acute exacerbations is recommended by national and international organizations.
Identifying high-risk dying patients on hospital admission helps in triaging them to the required level of care.
The use of early warning scores in follow-up is recommended for the early detection of critically ill patients and the prediction of clinical deterioration. CURB65, BAP65, qSOFA , DECAF and NEWS, which mainly involve mental status, respiratory rate, oxygen saturations, pulse, blood pressure, age, BUN level, etc., can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient presented to ED with acute exacerbation of COPD no gender discrimination from 18 years to unlimit age
Key inclusion criteria (1 listed)
- All patient presented to ED with acute exacerbation of COPD.
Key exclusion criteria (3 listed)
- Patient presented with acute insult affecting other system.
- Patient transferred to other centers.
- Inadequate data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the value of different scores in predicting hospital mortality
Time frame: one year
Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department as DECAF(dyspnea grade V according to eMRCD,esinopenia<0.05x10*9/L,consolidation,acidemia<7.30,atrial fibrillation) 1=mild,2_3=moderate,4_5=severe can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.
1 secondary outcome
Value of these scores in predicting need for MV.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 30130262Redfern OC, Smith GB, Prytherch DR, Meredith P, Inada-Kim M, Schmidt PE. A Comparison of the Quick Sequential (Sepsis-Related) Organ Failure Assessment Score and the National Early Warning Score in Non-ICU Patients With/Without Infection. Crit Care Med. 2018 Dec;46(12):1923-1933. doi: 10.1097/CCM.0000000000003359.
- Individual participant dataSharing planned: Undecided. sharing the result of the study after completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
reham mo abdelmonem, MD study director
Assiut Uneversity
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed mo saleh, bachelor (01128534859, drmohamed33333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the value of different scores in predicting hospital mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.