Clinical Trial: Efficacy and Safety of Using Noninvasive Ventilation in Cardiac Postoperative With Alveolar Recruitment Maneuver

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Using Non-Invasive Ventilation in Postoperative Revascularization of the Myocardium With Alveolar Recruitment Maneuver: Randomized Clinical Trial

Brief Summary: Heart surgery can evolve with complications in the postoperative phase, mainly of a respiratory nature, atelectasis and hypoxemia being the main pulmonary dysfunctions. They can lead to increased length of hospitalization, being the major cause of morbidity and mortality in the postoperative phase of heart surgery. In order to prevent or reduce such complications noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and therapeutic manner. The use of positive end expiratory pressure (PEEP) is already widely spread in intensive Care Unit (ICU), being used in patients under mechanical ventilation (MV), NIV and exercises with intermittent positive pressure and has huge scientific publication reporting its benefits for the pulmonary function. The alveolar recruitment maneuver (ARM) consists of sustained increase of pressure in the airway using PEEP in individuals with hypoxemia, in order to minimize the deleterious effects arising from alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma increasing the pulmonary area available for gas exchange and, consequently, arterial oxygenation. In recent years the increase in the application of PEEP in cardiopathic patients under MV has shown great benefits and the use of NIV to improve oxygenation by the reversal of atelectasis is already widely used and recommended in hospital routine. Despite NIV being used in great proportion, the relevant literature is poor in showing studies with NIV and ARM associated in heart surgery. Therefore, the objectives of this study are to evaluate if the use of NIV associated with ARM improves oxygenation in patients in postoperative revascularization of the myocardium related to usual use without ARM, and if it can be applied in a safe manner.

Detailed Summary:

This work was a randomized clinical trial, where patients were analyzed in postoperative phase of myocardial revascularization with extracorporeal circulation respecting the study inclusion and exclusion criteria. The secrecy of the location was achieved by opaque envelope and the electronic method was used for randomization.

Patients, doctors and nursing team did not know to which group the patient was randomized, only the physiotherapy team which was responsible for the therapy with use of noninvasive ventilation (NIV) knowing the group after randomization.

All the patients were ventilated in Servo I and to execute NIV they used the total face mask.

After extubation the patient who was randomized to the Control Group or Recruitment Group: Control Group use NIV for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, oxygen inspired fraction for a peripheral arterial Saturation of Oxygen (SpO2) ≥ 95%. Recruitment group use NIV with alveolar recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, oxygen inspired fraction for a SpO2 ≥ 95%.

The use of NIV was already routine of the institution and recommendation of the Brazilian Directives of MV and Brazilian Consensus of MV and did not have any potential risk. The execution of recruitment with NIV could have the risk of barotrauma, hemodynamic instability and arrhythmia.

The medical team would be called to evaluate the patient if clinical instability occurred during or after recruitment and would take the measured required for the integrity
Sponsor: Mieko Cláudia Miura

Current Primary Outcome:

  • Oxygenation improvement [ Time Frame: 1 month ]
    arterial gasometry
  • Atelectasis score improvement [ Time Frame: 1 month ]
    chest radiography
  • Extubation failure [ Time Frame: The failure rate of extubation was defined as the requirement of reintubation of the extubated patients within a 48hour period ]
  • Barotrauma [ Time Frame: 1 month ]
  • arrhythmia [ Time Frame: 1 month ]
  • hemodynamic instability [ Time Frame: intraoperative ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ICU lenght of stay [ Time Frame: 1 month ]
  • Mechanical ventilation duration [ Time Frame: 1 month ]
  • Mortality intrahospital [ Time Frame: 1 month ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: September 14, 2016
Date Started: April 2016
Date Completion: August 2017
Last Updated: September 22, 2016
Last Verified: September 2016