Congenital Heart DiseaseVENICENCT03629574
Mechanical Ventilation During Cardiopulmonary Bypass
A study testing Ventilation during cardiopulmonary bypass in people with Congenital Heart Disease and Mechanical Ventilation Complication, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Mechanical Ventilation Complication, Cardiopulmonary Bypass
- What is being tested?
- Ventilation during cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2018to Dec 2019
- Phase
- Interventional
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- congenital heart diseases
- younger than 5 years
- CPB longer than 30 minutes in hypotermia
- elective surgery
- stable clinical conditions
Who cannot join
- genetic anomalies
- mechanical ventilation before the surgery
- kidney injuries
- hepatic failure
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOPadova
Padova
Costantino Gallo, 049 8214439, ce.sperimentazione@aopd.veneto.it
About this study
Official title: Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas
The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs
- Being tested
- Ventilation during cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation during cardiopulmonary bypassProcedure or surgery
Mechanical ventilation during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Ventilated Group | Experimental | This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered. Receives: Procedure: Ventilation during cardiopulmonary bypass |
| Not-ventilated group | No intervention | This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
It will be assed the plasma level of proteins which usually are absent in the plasma (surfactant protein A and B) that change as a damage of the air-blood membrane appears.
Measured: Baseline, and 6, 12, 24 and 48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start20 Aug 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiana Carollo, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629574
- Sponsor's protocol ID
- 34365
- Acronym
- VENICE
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas
- ClinicalTrials.gov ID
- NCT03629574
- Acronym / sponsor ID
- VENICE / 34365
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 20 Aug 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Aug 2018 (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 study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilated Group | Experimental | Procedure: Ventilation during cardiopulmonary bypassThis group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered. |
| Not-ventilated group | No intervention | –This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- congenital heart diseases
- younger than 5 years
- CPB longer than 30 minutes in hypotermia
- elective surgery
- stable clinical conditions
Key exclusion criteria (4 listed)
- genetic anomalies
- mechanical ventilation before the surgery
- kidney injuries
- hepatic failure
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 |
|---|---|---|
| Ventilation during cardiopulmonary bypassMechanical ventilation during cardiopulmonary bypass | Procedure or surgery | Ventilated Group |
Primary outcome
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass
Time frame: Baseline, and 6, 12, 24 and 48 hours after the surgery
It will be assed the plasma level of proteins which usually are absent in the plasma (surfactant protein A and B) that change as a damage of the air-blood membrane appears.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation during cardiopulmonary bypass in people with Congenital Heart Disease and Mechanical Ventilation Complication, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass (time frame: Baseline, and 6, 12, 24 and 48 hours after the surgery). 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 14 Aug 2018.