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Lung Recruitment Improves Right Ventricle Performance

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ClinicalTrials.gov Identifier: NCT02795208
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Silvina Longo, Hospital Privado de Cordoba, Argentina

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.

Condition or disease Intervention/treatment Phase
Atelectasis Procedure: Lung recruitment maneuver Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
No Intervention: Control group
Patients received standard protective ventilation along the protocol.
Experimental: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Right ventricle assessment by transesophageal echocardiography [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Atelectasis assessment by transesophageal echocardiography [ Time Frame: intraoperative ]
  2. PaO2 and respiratory compliance [ Time Frame: intraoperative ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795208


Sponsors and Collaborators
Hospital Privado de Cordoba, Argentina
Investigators
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Principal Investigator: Silvina Longo, MD Hospital Privado de Córdoba
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Responsible Party: Silvina Longo, Medical Doctor, Hospital Privado de Cordoba, Argentina
ClinicalTrials.gov Identifier: NCT02795208    
Other Study ID Numbers: HPrivadoCordoba
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases