Thoracic SurgeryNCT03309280
Influence of Different Parameters on Extubation Time After Cardiac Surgery.
An observational study of Thoracic Surgery, run by Astes at 1 site in Belgium.
Trial summary
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Duration of intubation and Evolution of the renal function
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Oct 2017to 1 Jun 2018
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients scheduled for cardiac surgery in the Saint-Luc Bouge hospital.
Who may be able to join
- All patients for elective cardiac surgery
Who cannot join
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery.
Read the detailed description
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery. Several parameters of ventilation and infusion were recorded during surgery. A statistical analysis will be performed to determine if one of many of these are significant. The investigator does not assign specific interventions to the study participants, so the present study is observational and not interventional.
- Conditions
- Thoracic Surgery
- Being tested
- Duration of intubation, Evolution of the renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of intubationOther
Time between intubation in the operating room and exhumation in the Intensive Care Unit.
Evolution of the renal functionDiagnostic test
Evolution of the renal function in the next two days
| Study group | Role | What they receive |
|---|---|---|
| Patient at risk for OSA scheduled for Cardiac surgery | Patients with a positive STOP-Bang and DES-OSA score (that means patients at risk for OSA) Receives: Other: Duration of intubation; Diagnostic Test: Evolution of the renal function | |
| Patient not at risk for OSA scheduled for Cardiac surgery | Patients with a negative STOP-Bang and DES-OSA score (that means patients not at risk for OSA) Receives: Other: Duration of intubation; Diagnostic Test: Evolution of the renal function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of extubation
Time when extubation is performed
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start9 Oct 2017
- Primary completion3 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
- Investigators
- Eric Deflandre, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309280
- Sponsor's protocol ID
- VACC Study
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Parameters on Extubation Time After Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT03309280
- Acronym / sponsor ID
- VACC Study
- Conditions
- Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 13 Oct 2017 (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.
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery.
Detailed description
The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery. Several parameters of ventilation and infusion were recorded during surgery. A statistical analysis will be performed to determine if one of many of these are significant. The investigator does not assign specific interventions to the study participants, so the present study is observational and not interventional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient at risk for OSA scheduled for Cardiac surgery | – | Other: Duration of intubation, Diagnostic Test: Evolution of the renal functionPatients with a positive STOP-Bang and DES-OSA score (that means patients at risk for OSA) |
| Patient not at risk for OSA scheduled for Cardiac surgery | – | Other: Duration of intubation, Diagnostic Test: Evolution of the renal functionPatients with a negative STOP-Bang and DES-OSA score (that means patients not at risk for OSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for cardiac surgery in the Saint-Luc Bouge hospital.
Key inclusion criteria (1 listed)
- All patients for elective cardiac surgery
Key exclusion criteria (1 listed)
- Emergency procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duration of intubationTime between intubation in the operating room and exhumation in the Intensive Care Unit. | Other | Patient at risk for OSA scheduled for Cardiac surgery, Patient not at risk for OSA scheduled for Cardiac surgery |
| Evolution of the renal functionEvolution of the renal function in the next two days | Diagnostic test | Patient at risk for OSA scheduled for Cardiac surgery, Patient not at risk for OSA scheduled for Cardiac surgery |
Primary outcome
Time of extubation
Time frame: 2 Days
Time when extubation is performed
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Eric Deflandre principal investigator
Astes
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 Thoracic Surgery, run by Astes 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 27 Jan 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?
Time of extubation (time frame: 2 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 27 Jan 2020.