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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02767687
Enrollment
80
Registered
2016-05-10
Start date
2013-09-30
Completion date
2014-11-30
Last updated
2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Heart Diseases

Keywords

Postoperative Care, Postoperative Period, Heart Surgery

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.

Interventions

OTHERNoninvasive ventilation

Twenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes. NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O).

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of central venous oxygen saturation to determine tissue perfusionThrough study completion, an average of 1 yearAll 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 perfusionThrough study completion, an average of 1 yearAll 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

MeasureTime frameDescription
Respiratory complications during hospitalizationThrough study completion, an average of 1 yearRespiratory 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 hospitalizationThrough study completion, an average of 1 yearHemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026