Lung Recruitment Improves Right Ventricle Performance

NCT ID: NCT02795208

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Patients received standard protective ventilation along the protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Recruitment maneuver group

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.

Group Type: EXPERIMENTAL

Lung recruitment maneuver

Intervention Type: PROCEDURE

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.

Interventions

Lung recruitment maneuver

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• TEE contraindications.
• Hemodynamically unstable
• Needi for inotropic support

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Privado de Cordoba, Argentina

OTHER

Sponsor Role: lead

Responsible Party

Silvina Longo

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvina Longo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Córdoba

Other Identifiers

HPrivadoCordoba

Identifier Type: -

Identifier Source: org_study_id