- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308524
Scoring Systems covid19
March 31, 2022 updated by: Ebtesam Mohamed Thabet, Assiut University
Role of Disease Severity Scoring Systems in Predicting Mortality covid19 Pts in AUH
In this study, we planned to investigate the role and determine the predictive performance of both APACHE II and SAPS II scoring systems and compare them in COVID-19 patients admitted to the intensive care unit of Assiut University Hospital.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Since the start of the coronavirus disease 2019 (COVID-19) pandemic, intensive care units (ICUs) worldwide have struggled to treat affected patients who require a completely different approach to treatment than other patients
- [1]* .This study aims to evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anaesthesia alone.Although many severe cases are admitted to ICUs, it is unknown whether the conventional disease-severity scoring systems that were developed for ICU patients can be applied to patients with COVID-19.Several recent studies have used Acute Physiology and Chronic Health Evaluation (APACHE) and Simplified Acute Physiology Score (SAPS) to provide information on the clinical severity of COVID-19
- [2-4]*. However, very few reports have examined their validity of applying them to patients with COVID-19.
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ebtesam Mohamed thabet, 1
- Phone Number: 01020135853
- Email: ebtesamm582@gmail.com
Study Contact Backup
- Name: Amany Omar Mohamed
- Phone Number: 0111252424 9
- Email: amanyomd@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Sample size was calculated using Epi- Info7.
Based on previous studies the mortality rate of Covid-19 ICU admitted patients varies between countries, in low resources sittings the mortality rate was around 50% *[7 ]*.
With a confidence limits of 10% and a confidence level of 90% the minimum number of patients required for this study is 70 patients
Description
Inclusion Criteria:•
- • This study will be conducted on laboratory-confirmed COVID-19 patients who will be transferred to the intensive care unit of Assiut University Hospital
Exclusion Criteria:
- Patients would be excluded from this study if they died or were discharged from the intensive care unit prior collection of data required for both the APACHE II and SAPS II scoring systems, if they were discharged before their outcomes were determined and if we could not obtain consent from them or their companions to participate in this study. All patients involved will be subjected to a full history with special stress on age, gender, special habits, and associated diseases. Information such as the patient's need for ventilatory support as well as the length of ICU stay will be entered. Also, the laboratory results and Imaging findings will be registered. Scores of APACHE II and SAPS II were calculated as illustrated in the previously published works *[5,6]* .Patients will be followed up until their outcome was determined.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU scoring system in covid 19
Time Frame: Baseline
|
SAPS ,APACHE ICU scoring system in covid 19
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available. Erratum In: Lancet Infect Dis. 2020 Sep;20(9):e215.
- Michard F, Vieillard-Baron A. Critically ill patients with COVID-19: are they hemodynamically unstable and do we know why? Intensive Care Med. 2021 Feb;47(2):254-255. doi: 10.1007/s00134-020-06238-5. Epub 2020 Sep 10. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
March 31, 2022
First Submitted That Met QC Criteria
March 31, 2022
First Posted (Actual)
April 4, 2022
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICU scoring system in covid19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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