Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701908
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2012-09-30
Brief Title:
Postoperative Pulmonary Complications in Major Abdominal Surgery
Sponsor:
University of Udine
Organization:
University of Udine
Study Overview
Official Title:
Postoperative Pulmonary Complications in Major Abdominal Surgery a Multicenter Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Incidence of Postoperative Pulmonary Complications PPCs varies from 2 to 19 according to the population under examination and the criteria used to define pulmonary complications There is no univocal definition of PPCs Usually physicians associate atelectasis respiratory insufficiency pneumonia bronchospasm necessity to reintubate Moreover the evaluation of risk factors has become difficult
The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery general surgery gynecology urology
This is an observational descriptive prospective multicentric study Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge clinical phase Then they will be followed up until one year later
The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery general surgery gynecology urology
This is an observational descriptive prospective multicentric study Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge clinical phase Then they will be followed up until one year later
Detailed Description:
INTRODUCTION Pulmonary Postoperative Complications PPCs are among the most common causes of adverse events in the perioperative period and can determine a significant increase of mortality risk in hospitalization time
Incidence of PPCs varies from 2 to 19 according to the population under examination and the criteria used to define pulmonary complications There is no univocal definition of PPCs Usually physicians associate atelectasis respiratory insufficiency pneumonia bronchospasm necessity of tracheal reintubation Moreover the evaluation of risk factors is becoming increasingly difficult Many aspects linked to the patients conditions and postoperative anesthesiologic management have been demonstrated to influence the risk of developing PPCs with the endorsement of European Society of Anesthesiology proposed a risk index based on seven perioperative parameters to predict PPCs probability
Furthermore patients who survive after pulmonary complications will still suffer from functional reductions and are at risk of having a decrease in medium and long-term survival
PRIMARY END POINT To determine the actual incidence of respiratory postoperative complications in patients undergoing elective general anesthesia for major abdominal surgery general surgery urology gynecology
Respiratory complications are pneumonia respiratory insufficiency pleural effusion pneumothorax atelectasis ab ingestis pneumonia necessity of oxygen supply non invasive mechanical ventilation NIMV or tracheal reintubation
SECONDARY END POINTS
To determine
postoperative pulmonary complications rate in general gynecology and urology
length of hospital stay
unplanned postoperative Intensive care unit ICU admission and ICU length of stay
postoperative incidence of tracheal reintubation
postoperative incidence of infections
postoperative incidence of PostOperative Residual Curarization PORC
postoperative incidence of cardiovascular complications
postoperative mortality in-hospital 30 60 days and one year later
Duration of the clinical phase hospitalization data collection two hours after discharge from the operating room then from the first up to the fifth postoperative day and on the day of hospital discharge Duration of follow-up after hospitalization follow up period 30 days - 60 days - 1 year
RECRUITMENT AND MONITORING PROCEDURES All patients scheduled for elective major abdominal surgery urologic surgery or major gynecological surgery under general anaesthesia will be enrolled in this study
Patients will be enrolled over a 15 days period after that if the sample would be too small another 15 days enrollment period will be repeated
During the preoperative evaluation the anesthesiologist will expose the study protocol to all patients who will match the inclusion criteria The informed consent will be obtained
Patients will be monitored in the postoperative period and will receive standard postoperative care as directed by the clinical teams and if indicated antibiotics diuretics oxygen therapy and every therapy according to the underlying disease Medical and nursing staff will monitor peripheral oxygen saturation in the origin ward
In every center a researcher will evaluate the enrolled patients daily checking for peripheral oxygen saturation arterial pressure heart rate respiratory rate body temperature and pain assessment NRS scale
Patients clinical status until the hospital discharge will be reported on case report forms CRFs Every intraoperative parameter like drugs used the need of blood transfusion fluid management and fluid balance at the end of surgery will be recorded
Treatments and therapy will be continued according to clinicians decision and will be recorded in the CRF
The decision to start an oxygen therapy or a ventilatory support invasive or non-invasive or to admit the patient to the ICU will be taken by clinicians of every single participating center according to their guidelines
Every device used with oxygen flow values FiO2 PEEP and ventilation mode assistedmechanical will be noted in the CRF
Anesthesiologist will evaluate all the patients two hours after their return in the ward and from the first to the fifth postoperative day Anesthesiologists will be also on-call by the attending physician or the nursing staff every time patients clinical conditions will need it
Every patient will be followed and will be enrolled in the study until hospital discharge Date of discharge will be noted in the CRF
Moreover every enrolled patient will be followed-up at 30 60 days and a year after hospital discharge to verify the patients health status and to evaluate the incidence of re-hospitalization and mortality
DATA COLLECTION
A form divided in three sections preintrapostoperative period will be used for data collection Data will be collected on paper support and then entered in an electronic CRF
Data will be anonymous Every patient will be identified by a six number code first three from left to right identify the participating center the others identify the sequential number of enrollment
The data insertion will be done by the investigators of every participating center using personal username and password
Data will be sent to the coordinator center where the data cleaning will be completed and statistical analysis
Every center will store its own paper CRF
In the preoperative section will be recorded the patients data about
age weight height sex comorbidities neurological cardiovascular metabolic renal muscular-skeletal respiratory history positive for previous pleuro-parenchymal diseases in the 30 days before surgery previous chest pleural or lung surgery presence of pleural effusion history of cigarettes smoking active smoker history of alcohol abuse active cancer excluding the diagnosis for surgery SpO2 PaO2 PaO2FiO2 PaCO2 when available white cell number hemoglobin and preoperative creatinine ASA class presence of nasogastric tube before surgery presence of urinary catheter before surgery blood products transfusion before surgery
In the intraoperative section will be recorded the patients data about
type of surgery type of anaesthesia TIVA balanced type of analgesia intravenous epidural perineural block preoperative antibiotic prophylaxis blood products transfusion intraoperative fluid management crystalloids Vs colloids mLKgh type of ventilation PCVVCV ventilation parameters TV Pins PEEP RR FiO2 recruitment maneuvers yesno manuals pressure controlled intraoperative ventilatory problems SpO2 90 PaO2FiO2 300 PaCO2 45 mmHg increase of airways pressure over than 30 cmH2O bronchospasm needs of TV 10 mLKg hemorrhage or need of blood products transfusion cardiovascular problems hypotension tachycardia bradycardia arrhythmia and use of cardiovasoactive drugs
length of surgery
use of qualitative or quantitative TOF Watch neuromuscular transmission monitoring systems use of neostigmine or sugammadex
Final TOF ratio
In the postoperative section will be recorded the following data
pain score at discharge from the operating room and up to the fifth postoperative day needs of blood products transfusion in the postoperative period stay of nasogastric tube
stay of urinary catheter
postoperative respiratory complications
postoperative non-respiratory complications cardiovascular renal surgical infections
needs of re-intubation in the postoperative period
needs of ventilatory support non invasive ventilation invasive ventilation in the postoperative period needs of ICU admission planned unplanned cause length of ICU stay length of hospital stay 30 60 days and 1 year mortality specify the cause
STATISTICAL PLANS
Investigators are going to enroll 1500 patients undergoing elective major abdominal surgery in a period of 15 days It will be possible to add 15 extra days On the basis of works published by Squadrone et al11 16 Lawrence etal 17 45 Hall et al 18 15 Mitchell etal 19 11 and Canet et al 72 10 the hypothesis was that the incidence of primary outcome will be 7
The sample size has been calculated using alpha 005 2-tailed test and CI of 95
The result of this calculation is a sample size of 1422 Investigators decided to enroll 1500 patients because this way our population will be heterogeneous and because of possible deviations from the protocol
The statistic analysis will include
descriptive statistics of all the collected data average median standard deviation interquartile range minimum and maximum for the continuous variables relative and absolute frequency for the qualitative variables
interdependence between two or more variables if present
Statistic comparison between continuous variables using t-Student test if the variable has a normal distribution or non-parametric tests
Comparison between qualitative variables using Chi-square test
Odds ratio
Logistic regression
The study will include the possibility to perform non-planned analyses if useful
The data will be saved on an electronic support and analyzed with SPSS
Incidence of PPCs varies from 2 to 19 according to the population under examination and the criteria used to define pulmonary complications There is no univocal definition of PPCs Usually physicians associate atelectasis respiratory insufficiency pneumonia bronchospasm necessity of tracheal reintubation Moreover the evaluation of risk factors is becoming increasingly difficult Many aspects linked to the patients conditions and postoperative anesthesiologic management have been demonstrated to influence the risk of developing PPCs with the endorsement of European Society of Anesthesiology proposed a risk index based on seven perioperative parameters to predict PPCs probability
Furthermore patients who survive after pulmonary complications will still suffer from functional reductions and are at risk of having a decrease in medium and long-term survival
PRIMARY END POINT To determine the actual incidence of respiratory postoperative complications in patients undergoing elective general anesthesia for major abdominal surgery general surgery urology gynecology
Respiratory complications are pneumonia respiratory insufficiency pleural effusion pneumothorax atelectasis ab ingestis pneumonia necessity of oxygen supply non invasive mechanical ventilation NIMV or tracheal reintubation
SECONDARY END POINTS
To determine
postoperative pulmonary complications rate in general gynecology and urology
length of hospital stay
unplanned postoperative Intensive care unit ICU admission and ICU length of stay
postoperative incidence of tracheal reintubation
postoperative incidence of infections
postoperative incidence of PostOperative Residual Curarization PORC
postoperative incidence of cardiovascular complications
postoperative mortality in-hospital 30 60 days and one year later
Duration of the clinical phase hospitalization data collection two hours after discharge from the operating room then from the first up to the fifth postoperative day and on the day of hospital discharge Duration of follow-up after hospitalization follow up period 30 days - 60 days - 1 year
RECRUITMENT AND MONITORING PROCEDURES All patients scheduled for elective major abdominal surgery urologic surgery or major gynecological surgery under general anaesthesia will be enrolled in this study
Patients will be enrolled over a 15 days period after that if the sample would be too small another 15 days enrollment period will be repeated
During the preoperative evaluation the anesthesiologist will expose the study protocol to all patients who will match the inclusion criteria The informed consent will be obtained
Patients will be monitored in the postoperative period and will receive standard postoperative care as directed by the clinical teams and if indicated antibiotics diuretics oxygen therapy and every therapy according to the underlying disease Medical and nursing staff will monitor peripheral oxygen saturation in the origin ward
In every center a researcher will evaluate the enrolled patients daily checking for peripheral oxygen saturation arterial pressure heart rate respiratory rate body temperature and pain assessment NRS scale
Patients clinical status until the hospital discharge will be reported on case report forms CRFs Every intraoperative parameter like drugs used the need of blood transfusion fluid management and fluid balance at the end of surgery will be recorded
Treatments and therapy will be continued according to clinicians decision and will be recorded in the CRF
The decision to start an oxygen therapy or a ventilatory support invasive or non-invasive or to admit the patient to the ICU will be taken by clinicians of every single participating center according to their guidelines
Every device used with oxygen flow values FiO2 PEEP and ventilation mode assistedmechanical will be noted in the CRF
Anesthesiologist will evaluate all the patients two hours after their return in the ward and from the first to the fifth postoperative day Anesthesiologists will be also on-call by the attending physician or the nursing staff every time patients clinical conditions will need it
Every patient will be followed and will be enrolled in the study until hospital discharge Date of discharge will be noted in the CRF
Moreover every enrolled patient will be followed-up at 30 60 days and a year after hospital discharge to verify the patients health status and to evaluate the incidence of re-hospitalization and mortality
DATA COLLECTION
A form divided in three sections preintrapostoperative period will be used for data collection Data will be collected on paper support and then entered in an electronic CRF
Data will be anonymous Every patient will be identified by a six number code first three from left to right identify the participating center the others identify the sequential number of enrollment
The data insertion will be done by the investigators of every participating center using personal username and password
Data will be sent to the coordinator center where the data cleaning will be completed and statistical analysis
Every center will store its own paper CRF
In the preoperative section will be recorded the patients data about
age weight height sex comorbidities neurological cardiovascular metabolic renal muscular-skeletal respiratory history positive for previous pleuro-parenchymal diseases in the 30 days before surgery previous chest pleural or lung surgery presence of pleural effusion history of cigarettes smoking active smoker history of alcohol abuse active cancer excluding the diagnosis for surgery SpO2 PaO2 PaO2FiO2 PaCO2 when available white cell number hemoglobin and preoperative creatinine ASA class presence of nasogastric tube before surgery presence of urinary catheter before surgery blood products transfusion before surgery
In the intraoperative section will be recorded the patients data about
type of surgery type of anaesthesia TIVA balanced type of analgesia intravenous epidural perineural block preoperative antibiotic prophylaxis blood products transfusion intraoperative fluid management crystalloids Vs colloids mLKgh type of ventilation PCVVCV ventilation parameters TV Pins PEEP RR FiO2 recruitment maneuvers yesno manuals pressure controlled intraoperative ventilatory problems SpO2 90 PaO2FiO2 300 PaCO2 45 mmHg increase of airways pressure over than 30 cmH2O bronchospasm needs of TV 10 mLKg hemorrhage or need of blood products transfusion cardiovascular problems hypotension tachycardia bradycardia arrhythmia and use of cardiovasoactive drugs
length of surgery
use of qualitative or quantitative TOF Watch neuromuscular transmission monitoring systems use of neostigmine or sugammadex
Final TOF ratio
In the postoperative section will be recorded the following data
pain score at discharge from the operating room and up to the fifth postoperative day needs of blood products transfusion in the postoperative period stay of nasogastric tube
stay of urinary catheter
postoperative respiratory complications
postoperative non-respiratory complications cardiovascular renal surgical infections
needs of re-intubation in the postoperative period
needs of ventilatory support non invasive ventilation invasive ventilation in the postoperative period needs of ICU admission planned unplanned cause length of ICU stay length of hospital stay 30 60 days and 1 year mortality specify the cause
STATISTICAL PLANS
Investigators are going to enroll 1500 patients undergoing elective major abdominal surgery in a period of 15 days It will be possible to add 15 extra days On the basis of works published by Squadrone et al11 16 Lawrence etal 17 45 Hall et al 18 15 Mitchell etal 19 11 and Canet et al 72 10 the hypothesis was that the incidence of primary outcome will be 7
The sample size has been calculated using alpha 005 2-tailed test and CI of 95
The result of this calculation is a sample size of 1422 Investigators decided to enroll 1500 patients because this way our population will be heterogeneous and because of possible deviations from the protocol
The statistic analysis will include
descriptive statistics of all the collected data average median standard deviation interquartile range minimum and maximum for the continuous variables relative and absolute frequency for the qualitative variables
interdependence between two or more variables if present
Statistic comparison between continuous variables using t-Student test if the variable has a normal distribution or non-parametric tests
Comparison between qualitative variables using Chi-square test
Odds ratio
Logistic regression
The study will include the possibility to perform non-planned analyses if useful
The data will be saved on an electronic support and analyzed with SPSS
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