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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Other: recruitment group (RG); Other: control group (CG)

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
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation improvement	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.	from date of extubation until the date of ICU discharge, approximately one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atelectasis score improvement	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.	from date of extubation until the date of ICU discharge, approximately one month
Barotrauma	Occurrence of pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumoperitoneum during or after noninvasive ventilation associated or not to recruitment maneuver.	from date of extubation until the date of ICU discharge, approximately one month
Arrhythmia	Occurrence of cardiac arrhythmia during or after noninvasive ventilation associated or not to recruitment maneuver.	from date of extubation until the date of ICU discharge, approximately one month
Hemodynamic instability	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.	from date of extubation until the date of ICU discharge, approximately one month
Extubation failure rate	The failure of extubation was defined as the requirement of reintubation of the extubated patients within a 48hour period.	from date of extubation until the date of ICU discharge, approximately one month
ICU lenght of stay	Number of days that the patient stayed at the ICU.	from date of ICU admission until the date of ICU discharge, approximately one month
Mortality intrahospital	Occurrence of death during hospital stay.	from date of hospital admission until the date of hospital discharge, approximately one month

Collaborators and Investigators

• Sponsor: Mieko Cláudia Miura
• Collaborators: Hospital do Coracao
• Investigators: Principal Investigator: Carolina Fu, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: noninvasive ventilation; hypoxia; coronary artery bypass grafting; extracorporeal circulation; myocardial revascularization; pulmonary atelectasis; positive end-expiratory pressure
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 044/16; 298/2014 (Registry Identifier: Committees of Ethics in Research of the Hospital do Coração)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No