Survey: COVID-19 Patients Managed in the Operating Theatr... | NCT04376398

Studies
Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals

NCT04376398

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Belgium

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

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Aug 30, 2020Actual

First Submitted Date

May 4, 2020

First Submission Date that Met QC Criteria

May 4, 2020

First Posted Date

May 6, 2020Actual

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

Nov 2, 2020

Last Update Posted Date

Nov 3, 2020Actual

Name	Class
Society for Anesthesia and Resuscitation of Belgium	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

COVID-19 pandemic has an important impact on the health care provided by the anesthesiologists. Different societies of anesthesiology have provided guidelines and recommendations on how to manage patients who have been tested positive for COVID-19 or suspected to be infected. It is therefore important to know whether these guidelines have been implemented or were possible to be implemented. Otherwise patients who are presenting COVID-19 often show pulmonary complications. The airway management and the ventilation management of these patients can be therefore challenging and can possibly influence their outcome. It is thus important to obtain a large database with information about the characteristics of these patients, how these patients have been managed and their in-hospital outcome. Information regarding the correct implementation of guidelines is as well necessary for future guidance of health care providers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19		Any pediatric or adult patient with COVID-19 or suspected of COVID-19 scheduled for any intervention

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global evaluation of the implication of the Belgian anesthesiologists during COVID-19 pandemic	To evaluate whether Belgian anesthesiologists have followed or could follow the recommendations regarding the management of COVID-19 patients and what were the characteristics of these patients and how they have been managed and what were their outcomes	30 days

Secondary Outcomes

Measure	Description	Time Frame
If any compare our results with other countries	To compare the descriptives and the outcome data of our patients with other countries	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected

Exclusion Criteria: No oral consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All pediatric and adult patients who are tested positive for COVID-19 or who are suspected to be infected and who require anesthesia care for their intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc		Brussels			Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

All data will be provided to the Society for Anesthesia and Resuscitation of Belgium

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided