Lung Recruitment Improves Right Ventricle Performance

Atelectasis Clinical Trial

Official title:

Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795208
• Other study ID #: HPrivadoCordoba
• Status: Completed
• Phase: N/A
• First received: June 5, 2016
• Last updated: June 12, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Hospital Privado de Cordoba, Argentina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atelectasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Cordoba, Argentina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricle assessment by transesophageal echocardiography		intraoperative	No
Secondary	Atelectasis assessment by transesophageal echocardiography		intraoperative	No
Secondary	PaO2 and respiratory compliance		intraoperative	No