ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in Cardiac Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02913391
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Hospital do Coracao
Information provided by (Responsible Party):
Mieko Cláudia Miura, University of Sao Paulo

Brief Summary:
Cardiac surgery can evolve with complications in the postoperative period, atelectasis and hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay in the hospital, increasing morbidity and mortality. In order to prevent or reduce such complications noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and therapeutic way. The use of positive end-expiratory pressure (PEEP) is widely practice in intensive care unit (ICU), being used in patients under mechanical ventilation, NIV and exercises with intermittent positive pressure. The recruitment maneuver (RM) consists of sustained increase of pressure in the airway using PEEP in individuals with hypoxemia, in order to minimize the deleterious effects 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 cardiac patients under has shown great benefits and the use of NIV to improve oxygenation by the reversal of atelectasis is already used and recommended in hospital routine. Despite NIV being used in great proportion, the relevant literature is poor in showing studies with NIV associated with RM in postoperative period of cardiac surgery. Therefore, the aims of this study are to evaluate if the use of NIV associated with RM improves oxygenation and if it can be safely applied in coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) postoperative patients.

Condition or disease Intervention/treatment Phase
Hypoxia Other: recruitment group (RG) Other: control group (CG) Not Applicable

Detailed Description:

This work was a controlled and randomized clinical trial, where patients were analyzed in postoperative period of CABG with CPB. The protocol study was approved by Ethics Committee of the Faculty of Medicine, University os São Paulo and the Ethics Committee of the Hospital do Coração. Written informed consent was obtained from the patients or their surrogates at the thime of their enrollment.

Patients, doctors and nursing team were blinded to which group the patient was allocated, only the physiotherapy team, responsible for applying NIV therapy in the study, was aware of group allocation after randomization.

All the patients were ventilated in Servo I (MAQUET Critical Care AB™, Sweden) and used the FitLife total face mask (Philips Respironics™, USA).

Randomization was performed using a computer-based software. Patients eligible to the study were randomly assigned to the Control Group (CG) or Recruitment Group (RG).

CG used NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, fractional inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. RG used NIV with RM with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each level, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.

Patients were monitored during the whole NIV session.The RM would be interrupted and medical staff would be called to check the patient if any clinical instability occurred during or after RM, such as barotrauma, respiratory instability, hemodynamic instability and arrhythmia.

Medical staff would take the required measures for the safety of the patient.

Safety criteria for Interruption of RM:

  • respiratory rate > 35 breaths per minute;
  • heart rate >120 beats per minute or < 20 points from baseline;
  • Systolic blood pressure < 90 mmHg or > 16 mmHg;
  • Cardiac arrhythmia;
  • Patient's request. The patients used NIV three times per day until discharge from the ICU, the arterial blood gas and chest radiograph examinations were collected as sector routine. The arterial blood samples was collected after 2 minutes in room air and chest radiograph without NIV.

All postoperative patients of the ICU had NIV therapy once in the morning, once in the afternoon, once at night and only the physiotherapist applied NIV. All the patients were guided concerning how their therapy would be and, if they had queries, they were clarified before the start.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in the Postoperative Period of Coronary Artery Bypass Grafting: a Controlled Randomized Clinical Trial.
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: recruitment group (RG)
After extubation the patient who was randomized to the Recruitment Group (RG) used noninvasive ventilation (NIV) associated with recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV until 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%.
Other: recruitment group (RG)
After extubation the patient who was randomized to the Recruitment Group will use noninvasive ventilation (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, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.

Active Comparator: control group (CG)
After extubation the patient who was randomized to the Control Group (CG) used noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.
Other: control group (CG)
After extubation the patient who was randomized to the Control Group will use noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.




Primary Outcome Measures :
  1. Oxygenation improvement [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    Arterial blood gas sample was collected in pressure support ventilation on the day of extubation and on the following days, it was collected after 2 minutes in room air, daily until ICU discharge. Oxygenation improvement was the difference between partial oxygen pressure at the day of ICU discharge and the day of extubation.


Secondary Outcome Measures :
  1. Atelectasis score improvement [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    Radiological Atelectasis Score was attributed by a physician not related to the study, according to chest radiograph, with the following scores: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.

  2. Barotrauma [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    Occurrence of pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumoperitoneum during or after noninvasive ventilation associated or not to recruitment maneuver.

  3. Arrhythmia [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    Occurrence of cardiac arrhythmia during or after noninvasive ventilation associated or not to recruitment maneuver.

  4. Hemodynamic instability [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    Occurrence of heart rate > 120 beats per minute or < 20 points from baseline value, systolic blood pressure < 90 or > 160 mmHg during or after noninvasive ventilation associated or not to recruitment maneuver.

  5. Extubation failure rate [ Time Frame: from date of extubation until the date of ICU discharge, approximately one month ]
    The failure of extubation was defined as the requirement of reintubation of the extubated patients within a 48hour period.

  6. ICU lenght of stay [ Time Frame: from date of ICU admission until the date of ICU discharge, approximately one month ]
    Number of days that the patient stayed at the ICU.

  7. Mortality intrahospital [ Time Frame: from date of hospital admission until the date of hospital discharge, approximately one month ]
    Occurrence of death during hospital stay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years or over;
  • Hypoxemia defined by ratio PaO2/FiO2 < 300 in extubation;
  • Glasgow Coma Scale > 11 after extubation;
  • Chest radiograph with radiological atelectasis score ≥ 2 The radiological score of atelectasis: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.

Exclusion Criteria:

  • Use of vasoconstrictor drugs in increasing doses throughout the last two hours (norepinephrine increasing ≥ 0.5 mcg / kg / min, or increase of dopamine ≥ 5mcg/kg/min) or arterial pressure <65 mmHg;
  • Presence of a tracheostomy;
  • Global initiative for Obstructive Lung Disease (GOLD) classification > 2 and pulmonary fibrosis;
  • Contraindication to use of NIV;
  • Refuse of RM by the surgeon / doctor in charge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913391


Locations
Brazil
Hospital do Coracao
Sao Paulo, Brazil
Sponsors and Collaborators
Mieko Cláudia Miura
Hospital do Coracao
Investigators
Principal Investigator: Carolina Fu, PhD University of Sao Paulo

Responsible Party: Mieko Cláudia Miura, Post graduating, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of São Paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02913391     History of Changes
Other Study ID Numbers: 044/16
298/2014 ( Registry Identifier: Committees of Ethics in Research of the Hospital do Coração )
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Authors may accept to share data regarding baseline characteristics and results. Researchers with interest in the study should contact us by email to request. The request will be analyzed by the study authors.

Keywords provided by Mieko Cláudia Miura, University of Sao Paulo:
noninvasive ventilation
myocardial revascularization
pulmonary atelectasis
hypoxia
positive end-expiratory pressure
coronary artery bypass grafting
extracorporeal circulation

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms