- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758286
Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19
February 16, 2021 updated by: Adel F. Alkholy, Benha University
Protocol for Anesthesia for Emergency Surgery
A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All COVID-19 patients who were admitted to emergency departments presenting with emergency surgical conditions were evaluated for assurance of having COVID-19 disease.
Then, the appropriate anesthetic procedure was applied and the appropriate surgical intervention was performed.
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Qalubia
-
Banhā, Qalubia, Egypt, 0013
- Faculty of Medicine
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Assured diagnosis of COVID-19 by RT-PCR
Exclusion Criteria:
- No
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Successful outcome
It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication
|
COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
Other Names:
|
Active Comparator: Complicated outcome
It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication
|
COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire
Time Frame: Up to two days
|
This questionnaire was designed to assess the satisfaction of the anesthetist in-charge and the surgeon by the applied protocol to manage COVID-19 patients
|
Up to two days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiologic assessment
Time Frame: Up to one day
|
estimation of systolic and diastolic blood pressures of patients during and after surgery
|
Up to one day
|
Surgical follow-up
Time Frame: Up to 10 days
|
Postoperative assessment of wounds and drainage tube, if any, and to determine the success of the procedure or the development of complications
|
Up to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
July 1, 2020
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 11, 2021
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 16, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
February 17, 2021
Last Update Submitted That Met QC Criteria
February 16, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Emergencies
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- RC2-2-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The study protocol may be shared
IPD Sharing Time Frame
after publishing
IPD Sharing Access Criteria
email
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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