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

NCT02767687 | Completed

• 1 other identifier: 1.156.460
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Diseases; Coronary Artery Disease

Keywords

Postoperative Care; Postoperative Period; Heart Surgery

Outcome Measures

Primary Outcomes (2)

• Evaluation of central venous oxygen saturation to determine tissue perfusion

  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.

  Through study completion, an average of 1 year

• Evaluation of arterial lactate to determine tissue perfusion

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Respiratory complications during hospitalization

  Through study completion, an average of 1 year

• Hemodinamycs complications during hospitalization

  Through study completion, an average of 1 year

Study Arms (1)

Noninvasive ventilation (NIV)

EXPERIMENTAL

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.

Other: Noninvasive ventilation

Interventions

Noninvasive ventilation OTHER

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).

Also known as: NIV

Noninvasive ventilation (NIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• Marcondi NO, Rocco IS, Bolzan DW, Pauletti HO, Begot I, Anjos NR, Moreira RSL, Nasrala ML, Arena R, Gomes WJ, Guizilini S. Noninvasive Ventilation After Coronary Artery Bypass Grafting in Subjects With Left-Ventricular Dysfunction. Respir Care. 2018 Jul;63(7):879-885. doi: 10.4187/respcare.05851. Epub 2018 Jun 12.

  PMID: 29895702 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Solange Guizilini, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: May 10, 2016
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share