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During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways, there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL).
The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.
The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's necessary a study to assess both. The primary end-point of the study is to evaluate the correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay, the rehospitalization and mortality.
It will be a prospective, observational, non-pharmacological study. It will enroll 200 patients undergoing elective adult cardiac surgery.
During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways (closing capacity), there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL). Numerous factors contribute to the EFL, including hyperoxia, muscle paralysis, the increase of the volume of the interstitial fluids and the inflammatory response.
To establish the presence of EFL under general anesthesia, it was developed a test known as PEEP test. It is the sudden removal of 3 cm H2O to the value of positive end-expiratory pressure (PEEP test): in the EFL the subtraction of the expiratory pressure does not produce an increase of expiratory flow. The use of different modality of mechanical ventilation during cardiac surgery may impact on the incidence of EFL post CEC.
The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.
The primary end-point of the study will be:
- Evaluate the correlation of DP and EFL with PPCs in patients undergoing elective cardiac surgery performed with extracorporeal circulation.
The secondary end-point of the study will be:
It will be a prospective, observational, non-pharmacological study. It will enroll 200 patients undergoing elective adult cardiac surgery.
Respiratory rate will be set to maintain PaCO2 at values close to eucapnia. It will be used to pressure-controlled ventilation (Pinsp ≤ 35 cm H2O) only if the controlled ventilation is reached and exceed the maximum airway pressures. In this case it will be necessary to check that the volume delivered by the ventilator is really, for the entire period, the chosen volume. The inspiratory way will be composed of O2, air and maybe the halogenated anesthetic. The O2 concentration will be increased gradually in case of desaturation up to maintain SpO2 93-95% trying not to exceed the FiO2 of 0.8 if it will be choice a protective ventilation strategy.
Weaning from the CEC will include a single alveolar recruitment maneuver, in which the airway pressure will be increased to 40 cm H20 for 7 seconds.
At the end the patients will be transferred to the Intensive Care Unit (ICU) for post-operative monitoring. During the transfer will be supported with mechanical ventilation performed manually by the anesthetist resuscitator.
Extubation in ICU will run in according to the protocol of the center. It could be used any postoperative analgesia that provides NRS at rest ≤ 3 and dynamic NRS (cough) ≤ 4 and allow an active chest physical therapy (CPT).
The following information will be collected:
In the section devoted to the preoperative treats will be fit the patient data related to:
In the dedicated intraoperatory tab will be collected the following data:
In the schedule about the post-operative treats will be collected the following data:
Data will be collected on the appropriate Case Report Form (CRF). It will be collected anamnestic information, data about surgery and post-operative clinical data, in particular respiratory parameters. Definitions and use of outcome measures are in according to the standards for European Perioperative Clinical Outcome (EPCO) definitions [Eur J Anaesthesiol 2015; 32:88-105].
Data will be analyzed with a professional statistical software. Univariate and multivariate analysis will be performed. Chi-square test will be used for dichotomous variables, z-test/t-test or the Mann-Whitney U-test for continuous variables, as appropriate. Statistical significance if p <0.05.
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| Measure | Description | Time Frame |
|---|---|---|
| Expiratory Flow Limitation | Through study completion, an average of 24 hours after surgery | |
| Incidence of Driving Pressure | Through study completion, an average of 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complication | Respiratory Failure, Pneumothorax, Atelectasis, Respiratory Infection, Bronchospasm, Pleural Effusion | Through study completion, an average of 7 days after surgery |
| ICU length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Undergoing Elective Cardiac Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Elena Bignami, MD | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Milan | MI | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27875410 | Background | Grieco DL, Chen L, Dres M, Brochard L. Should we use driving pressure to set tidal volume? Curr Opin Crit Care. 2017 Feb;23(1):38-44. doi: 10.1097/MCC.0000000000000377. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D011030 | Pneumothorax |
| D001261 | Pulmonary Atelectasis |
| D012141 | Respiratory Tract Infections |
| D001986 | Bronchial Spasm |
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010995 | Pleural Diseases |
| D008171 | Lung Diseases |
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| Through study completion, an average of 24 hours after surgery |
| Hospital length of stay | Through study completion, an average of 7 days after surgery |
| Duration of mechanical ventilation | Through study completion, an average of 7 days after surgery |
| PaO2/ FiO2 | Through study completion, an average of 24 hours after surgery |
| Mortality | Through study completion, an average of 7 days after surgery |
| D007239 |
| Infections |
| D001982 | Bronchial Diseases |