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Clinical Trials/NCT02767687
NCT02767687
Completed
Not Applicable

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

Federal University of São Paulo0 sites80 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Federal University of São Paulo
Enrollment
80
Primary Endpoint
Evaluation of central venous oxygen saturation to determine tissue perfusion
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
November 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Natasha de Oliveira Marcondi

Principal Investigator

Federal University of São Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluation of central venous oxygen saturation to determine tissue perfusion

Time Frame: 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

Time Frame: 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 Outcomes

  • Respiratory complications during hospitalization(Through study completion, an average of 1 year)
  • Hemodinamycs complications during hospitalization(Through study completion, an average of 1 year)

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