Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03064659
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2017-02-17
Brief Title:
Driving Pressure And EFL in Adult Cardiac Surgery
Sponsor:
Ospedale San Raffaele
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Driving Pressure And Limitation of Expiratory Flow Evaluation of Postoperative Pulmonary Complications in Elective Adult Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 its 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
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 its 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
Detailed Description:
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 08 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 3288-105
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-testt-test or the Mann-Whitney U-test for continuous variables as appropriate Statistical significance if p 005
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 08 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 3288-105
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-testt-test or the Mann-Whitney U-test for continuous variables as appropriate Statistical significance if p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None