Respiratory Failure Clinical Trial
Official title:
Driving Pressure And Limitation of Expiratory Flow: Evaluation of Postoperative Pulmonary Complications in 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, 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:
- Consider whether there are factors associated with the development of EFL, especially
comorbidities and ventilation mode during surgery;
- Evaluate outcomes such as duration of mechanical ventilation, length of stay in
intensive care (ICU), PaO2/ FiO2 at discharge from the ICU, development of respiratory
complications, duration of hospital stay and mortality.
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:
- Age, weight, height, sex;
- Comorbidities
- Positive respiratory history of: previous pleural-parenchymal disease within 30 days
prior to the intervention, previous surgery of the thorax, pleura or lung, presence of
pleural effusion;
- History of smoking cigarettes: Active smoking (number of cigarettes), ex-smoker or
non-smoker;
- SpO2, PaO 2, PaO 2 / FiO 2, PaCo 2 (if available);
- Cardiological history (echocardiography, ECG, etc.)
- Other medical history information of relevance to the study
In the dedicated intraoperatory tab will be collected the following data:
- Incidence of EFL and respiratory mechanics parameters;
- Type of surgery;
- Time to CEC, clamping, cardioplegia, type of circuit and oxygenator;
- Transfusion of blood products;
- Any administration of cardio / vasoactive drugs;
- Duration of surgery;
- Other information relevant for the purposes of the study.
In the schedule about the post-operative treats will be collected the following data:
- Postoperative mechanical ventilation time;
- Postoperative respiratory complications;
- Postoperative non-respiratory complications (cardiovascular, infectious, kidney,
surgical);
- The need for re-intubation in the postoperative period;
- The need for ventilatory support (non-invasive ventilation, invasive ventilation) in
the postoperative period;
- Need for hospitalization in intensive care (expected, unexpected, cause of
hospitalization, length of stay);
- Length of hospital stay;
- Other information about the postoperative relevant to the study The study does not
interfere with the normal anesthetic activity, it does not provide for variations from
the procedures currently used and the PEEP test use does not involve pathophysiological
changes for the patient.
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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