Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery

Not Applicable

Completed

• Conditions: Heart Diseases; Coronary Artery Disease
• Interventions: Other: Noninvasive ventilation

• Registration Number: NCT02767687
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.

Detailed Description

Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.

Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.

This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2016-03-28
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-07
• Last Update Submitted: 2016-05-07
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Presence of central venous catheter
• Invasive arterial pressure catheter
• Invasive mechanical ventilation

Exclusion Criteria

• Chronic obstructive pulmonary disease
• Morbid obesity
• Hemodynamic instability
• Spontaneous breathing
• Need of invasive mechanical ventilation for more than 24 hours
• Intolerance to noninvasive mechanical ventilation
• Extubation failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Noninvasive ventilation (NIV)	Noninvasive ventilation	Noninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function. It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient. The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes.

Primary Outcome Measures

Name	Time	Method
Evaluation of central venous oxygen saturation to determine tissue perfusion	Through study completion, an average of 1 year	All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
Evaluation of arterial lactate to determine tissue perfusion	Through study completion, an average of 1 year	All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.

Secondary Outcome Measures

Name	Time	Method
Respiratory complications during hospitalization	Through study completion, an average of 1 year	Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded.
Hemodinamycs complications during hospitalization	Through study completion, an average of 1 year	Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.