Intensive Alveolar Recruitment Protocol After Cardiac Surgery
Primary Purpose
Ventilator Induced Lung Injury, Cardiac Disease, Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intensive Alveolar Recruitment
Moderate Alveolar Recruitment
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Induced Lung Injury focused on measuring Mechanical ventilation, Open lung approach, Blood gases, Cardiac surgery, Pulmonary complications
Eligibility Criteria
Inclusion Criteria:
- Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
- Age > 18 years and < 80 years
- No previous pulmonary disease
- Left ventricular ejection fraction > 35%
- Body mass index < 40 kg/m2
- Oxygen index (PaO2/FiO2) < 250
- Corrected volemic status (negative raising legs mean arterial pressure [MAP] variation < 10%)
- Written inform consent
Exclusion Criteria:
- MAP (mean arterial pressure) < 60 mmHg
- Noradrenaline > 2 micrograms/Kg/min
- Acute arrhythmias
- Blooding associated to hemodynamic instability
- Need of re-surgery and/or mechanical circulatory assistance
- Suspicion of neurological alteration
- Chest tube with persistent air leak
Sites / Locations
- Instituto do Coração (Incor) - University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive Alveolar Recruitment
Moderate Alveolar Recruitment
Arm Description
Recruitment with opening pressures of 45 cmH2O in the airways.
Recruitment with opening pressures of 20 cmH2O in the airways.
Outcomes
Primary Outcome Measures
Severity of Pulmonary Complications in the Post-operative Period
Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.
The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.
Data shown are percentage of participants with pulmonary complications grade ≥ 3.
Secondary Outcome Measures
Length of ICU Stay
Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.
Length of Hospital Stay
Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.
Incidence of Barotrauma
Confirmed by X-ray. Test with logistic regression
Hospital Mortality
Deaths occurred during hospital stay, tested with logistic regression.
Full Information
NCT ID
NCT01502332
First Posted
December 21, 2011
Last Updated
October 1, 2016
Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT01502332
Brief Title
Intensive Alveolar Recruitment Protocol After Cardiac Surgery
Official Title
Comparison of Two Protective Mechanical Ventilation Strategies After Cardiac Surgery: Aggressive Versus Moderate Alveolar Recruitment Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate prospectively the impact of two protective mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery. The study selected patients presenting signals of deficient gas exchange (PaO2/FIO2 < 250 at a PEEP [positive end expiratory pressure] of 5 cmH2O) in the immediate post-operative period. An aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing period of four hours of controlled mechanical ventilation, the patients followed the routine weaning protocol and physiotherapy protocol of the institution.
Detailed Description
The postoperative period of cardiac surgery is associated with the development of pulmonary complications. Functional residual capacity can be reduced up to 50% and pulmonary volumes may be decreased until three months after surgery.
Lung injury is the result of pulmonary inflammation (activated by cardiopulmonary bypass, the surgical procedure itself and ischemia-reperfusion injury), the adopted mechanical ventilation strategy and a consequence of previous cardiac and/or pulmonary dysfunction.
The use of protective mechanical ventilation strategies with low tidal volumes since the immediate postoperative period, or since the operating room, has been shown to attenuate and prevent lung injury in previous studies selecting with high-risk patients.
A more complex topic, however, has been the proof of the additional benefit of alveolar recruitment maneuvers during the brief period of mechanical ventilation after surgery. While the experimental evidence suggests that the use of an open lung approach could minimize the shearing forces in the lung parenchyma, enhancing the protection afforded by low tidal volume ventilation, innumerous concerns about the hemodynamic side effects, and the possibility of barotrauma have prevented the routine use of intensive alveolar recruitment protocols. Another matter of concern is the net efficacy of a recruitment maneuver applied in the post-operative period, instead of the intra-operative period.
Thus, this study compared the impact of two protective mechanical ventilation strategies, both using low-tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery, in a selective population of patients presenting signals of deficient gas exchange (PaO2/FIO2 < 250 at a PEEP of 5 cmH2O) in the immediate post-operative period. In a previous study at this institution, this subgroup of patients was shown to be at higher risks of postoperative pulmonary complications.
During the short period of controlled mechanical ventilation after the patient arrival from the operating theater, an aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After an stabilizing period of four hours of controlled mechanical ventilation, the patients followed the routine weaning protocol and physiotherapy protocol of the institution.
Our hypothesis was that the aggressive alveolar recruitment strategy might help in the reversal of collapse created during the surgery and short term mechanical ventilation during anesthesia and patient transportation. Previous studies have shown that this effect may extend to the post-extubation period, impairing lung function for a few days.
Thus, we tested if the effect of an aggressive alveolar recruitment protocol was translated in a better lung compliance, better gas exchange, and fewer pulmonary complications in the post-operative periods (this latter was our primary outcome). Analysis of the length of stay was also scrutinized, consisting in our secondary outcome. All hemodynamic complications was reported, since we also anticipated that events of hemodynamic impairment might be more frequent in the aggressive recruitment arm, eventually obscuring the expected benefits .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Induced Lung Injury, Cardiac Disease, Acute Lung Injury
Keywords
Mechanical ventilation, Open lung approach, Blood gases, Cardiac surgery, Pulmonary complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Alveolar Recruitment
Arm Type
Experimental
Arm Description
Recruitment with opening pressures of 45 cmH2O in the airways.
Arm Title
Moderate Alveolar Recruitment
Arm Type
Active Comparator
Arm Description
Recruitment with opening pressures of 20 cmH2O in the airways.
Intervention Type
Other
Intervention Name(s)
Intensive Alveolar Recruitment
Intervention Description
Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with tidal volume (VT) = 6 mL/kg/pbw.
Intervention Type
Other
Intervention Name(s)
Moderate Alveolar Recruitment
Intervention Description
Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
Primary Outcome Measure Information:
Title
Severity of Pulmonary Complications in the Post-operative Period
Description
Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.
The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.
Data shown are percentage of participants with pulmonary complications grade ≥ 3.
Time Frame
Participants were followed for the duration of hospital stay.
Secondary Outcome Measure Information:
Title
Length of ICU Stay
Description
Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.
Time Frame
From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery
Title
Length of Hospital Stay
Description
Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.
Time Frame
From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery
Title
Incidence of Barotrauma
Description
Confirmed by X-ray. Test with logistic regression
Time Frame
Five days after surgery
Title
Hospital Mortality
Description
Deaths occurred during hospital stay, tested with logistic regression.
Time Frame
From the day of surgery up to Hospital discharge or death, with no maximum censoring.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
Age > 18 years and < 80 years
No previous pulmonary disease
Left ventricular ejection fraction > 35%
Body mass index < 40 kg/m2
Oxygen index (PaO2/FiO2) < 250
Corrected volemic status (negative raising legs mean arterial pressure [MAP] variation < 10%)
Written inform consent
Exclusion Criteria:
MAP (mean arterial pressure) < 60 mmHg
Noradrenaline > 2 micrograms/Kg/min
Acute arrhythmias
Blooding associated to hemodynamic instability
Need of re-surgery and/or mechanical circulatory assistance
Suspicion of neurological alteration
Chest tube with persistent air leak
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo BP Amato, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Instituto do Coração (Incor) - University of São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28322416
Citation
Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.
Results Reference
derived
Learn more about this trial
Intensive Alveolar Recruitment Protocol After Cardiac Surgery
We'll reach out to this number within 24 hrs