Scoring Systems covid19 | NCT05308524

Studies
Scoring Systems covid19

NCT05308524

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 4, 2022Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

ICU Scoring System in Covid 19

Interventions

ICU scoring system in covid 19

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Estimated

Primary Completion Date

Sep 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Mar 31, 2022

First Submission Date that Met QC Criteria

Mar 31, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2022

Last Update Posted Date

Apr 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICU scoring system in covid 19	Diagnostic Test	The intensive care unit (ICU) at Assiut University Hospital, which is supervised by the staff members of the Chest Diseases Department and designated to deal with critically ill Covid 19 patients.

Measure	Description	Time Frame
ICU scoring system in covid 19	SAPS ,APACHE ICU scoring system in covid 19	Baseline

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ebtesam Mohamed thabet, 1	Contact	01020135853		ebtesamm582@gmail.com
Amany Omar Mohamed	Contact	0111252424 9		amanyomd@hotmail.com

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32087114	Background	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.
32910203	Background	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.