COVID-19COVIDNCT04376398
Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals
An observational study of COVID-19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 100 years
- Conditions the study is for
- COVID-19
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Apr 2020to 30 Aug 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey on Patients With Suspected or Confirmed COVID-19 Requiring Anesthesia Care for Their Intervention
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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Any pediatric or adult patient with COVID-19 or suspected of COVID-19 scheduled for any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
If any compare our results with other countries
To compare the descriptives and the outcome data of our patients with other countries
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start6 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Anesthesia and Resuscitation of Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376398
- Sponsor's protocol ID
- COVID-ANESTHESIO
- Acronym
- COVID
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be provided to the Society for Anesthesia and Resuscitation of Belgium
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Patients With Suspected or Confirmed COVID-19 Requiring Anesthesia Care for Their Intervention
- ClinicalTrials.gov ID
- NCT04376398
- Acronym / sponsor ID
- COVID / COVID-ANESTHESIO
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Society for Anesthesia and Resuscitation of Belgium
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | –Any pediatric or adult patient with COVID-19 or suspected of COVID-19 scheduled for any intervention |
Who may qualify
- Ages
- 1 hour to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global evaluation of the implication of the Belgian anesthesiologists during COVID-19 pandemic
Time frame: 30 days
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
1 secondary outcome
If any compare our results with other countries
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No. All data will be provided to the Society for Anesthesia and Resuscitation of Belgium
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global evaluation of the implication of the Belgian anesthesiologists during COVID-19 pandemic (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.