Lung Recruitment Improves Right Ventricle Performance

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.

Study Overview

• Status: Completed
• Conditions: Atelectasis
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Right ventricle assessment by transesophageal echocardiography	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Atelectasis assessment by transesophageal echocardiography	intraoperative
PaO2 and respiratory compliance	intraoperative

Collaborators and Investigators

• Sponsor: Hospital Privado de Cordoba, Argentina
• Investigators: Principal Investigator: Silvina Longo, MD, Hospital Privado de Cordoba

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 12, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: HPrivadoCordoba

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided