AtelectasisNCT02795208
Lung Recruitment Improves Right Ventricle Performance
A study testing Lung recruitment maneuver in people with Atelectasis, run by Hospital Privado de Cordoba, Argentina.
Trial summary
This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Lung recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2016
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiovascular surgery with cardiopulmonary bypass.
- Patients with a New York Heart Association (NYHA) class I-II,
- Pre-operative left ventricular ejection fraction ≥ 50 %.
- Euroscore ≤ 6.
Who cannot join
- TEE contraindications.
- Hemodynamically unstable
- Needi for inotropic support
About this study
Official title: Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass
This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.
Read the detailed description
Atelectasis is developed in 90% of anesthetized patients after surgery.
Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex).
Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.
- Conditions
- Atelectasis
- Being tested
- Lung recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung recruitment maneuverProcedure or surgery
The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients received standard protective ventilation along the protocol. |
| Recruitment maneuver group | Experimental | Patient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open. Receives: Procedure: Lung recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle assessment by transesophageal echocardiography
Measured: intraoperative
Secondary outcomes (2)
Atelectasis assessment by transesophageal echocardiography
Measured: intraoperative
PaO2 and respiratory compliance
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Cordoba, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvina Longo, Hospital Privado de Cordoba, Argentina
- Investigators
- Silvina Longo, MD, Principal investigator, Hospital Privado de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795208
- Sponsor's protocol ID
- HPrivadoCordoba
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass
- ClinicalTrials.gov ID
- NCT02795208
- Acronym / sponsor ID
- HPrivadoCordoba
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Privado de Cordoba, ArgentinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jun 2016 (estimated)
- 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.
This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.
Detailed description
Atelectasis is developed in 90% of anesthetized patients after surgery.
Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex).
Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients received standard protective ventilation along the protocol. |
| Recruitment maneuver group | Experimental | Procedure: Lung recruitment maneuverPatient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cardiovascular surgery with cardiopulmonary bypass.
- Patients with a New York Heart Association (NYHA) class I-II,
- Pre-operative left ventricular ejection fraction ≥ 50 %.
- Euroscore ≤ 6.
Key exclusion criteria (3 listed)
- TEE contraindications.
- Hemodynamically unstable
- Needi for inotropic support
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 |
|---|---|---|
| Lung recruitment maneuverThe lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths. | Procedure or surgery | Recruitment maneuver group |
Primary outcome
Right ventricle assessment by transesophageal echocardiography
Time frame: intraoperative
2 secondary outcomes
Atelectasis assessment by transesophageal echocardiography
Time frame: intraoperative
PaO2 and respiratory compliance
Time frame: intraoperative
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 14 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Silvina Longo, MD principal investigator
Hospital Privado de Córdoba
Questions about this trial
What is this clinical trial studying?
A study testing Lung recruitment maneuver in people with Atelectasis, run by Hospital Privado de Cordoba, Argentina.
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 4 inclusion and 3 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Right ventricle assessment by transesophageal echocardiography (time frame: intraoperative). 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 Jun 2016.