NCT04758286

Brief Summary

A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

February 11, 2021

Last Update Submit

February 16, 2021

Conditions

Keywords

COVID-19AnesthesiaSurgeryOutcomes

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    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 Outcomes (2)

  • Physiologic assessment

    Up to one day

  • Surgical follow-up

    Up to 10 days

Study Arms (2)

Successful outcome

ACTIVE COMPARATOR

It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication

Procedure: Emergency surgical procedures

Complicated outcome

ACTIVE COMPARATOR

It will include the anesthetic and operative data and the incidence of intraoperative or postoperative complication

Procedure: Emergency surgical procedures

Interventions

COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately

Also known as: Spinal anesthesia, Epidural anesthesia, Total intravenous anesthesia
Complicated outcomeSuccessful outcome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Assured diagnosis of COVID-19 by RT-PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Banhā, Qalyubia Governorate, 0013, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Anesthesia, SpinalAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Adel Alkholy, Prof

    Faculty of medicine, Banha University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An anesthetist who was not in charge for application of the protocol is responsible for assessing the intraoperative findings and another anesthetist was responsible for assessing the postoperative findings
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients presenting with surgical emergency
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Biochemistry

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

July 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 11, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

The study protocol may be shared

Shared Documents
STUDY PROTOCOL
Time Frame
after publishing
Access Criteria
email

Locations