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

NCT02913391 | Completed

• 2 other identifiers: 044/16298/2014
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

noninvasive ventilation; myocardial revascularization; pulmonary atelectasis; hypoxia; positive end-expiratory pressure; coronary artery bypass grafting; extracorporeal circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Atelectasis score improvement

  from date of extubation until the date of ICU discharge, approximately one month

• Barotrauma

  from date of extubation until the date of ICU discharge, approximately one month

• Arrhythmia

  from date of extubation until the date of ICU discharge, approximately one month

• Hemodynamic instability

  from date of extubation until the date of ICU discharge, approximately one month

• Extubation failure rate

  from date of extubation until the date of ICU discharge, approximately one month

Study Arms (2)

recruitment group (RG)

EXPERIMENTAL

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)

control group (CG)

ACTIVE COMPARATOR

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)

Interventions

recruitment group (RG) OTHER

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%.

recruitment group (RG)

control group (CG) OTHER

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%.

control group (CG)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mieko Cláudia Miura: lead
• Hospital do Coracao: collaborator

Study Sites (1)

Hospital do Coracao

São Paulo, Brazil

Location

MeSH Terms

Conditions

Hypoxia; Pulmonary Atelectasis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carolina Fu, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post graduating, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of São Paulo

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 23, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

BR (1)