Postoperative Pulmonary Complications in Abdominal Surgery
|First Received Date ICMJE||September 30, 2012|
|Last Updated Date||October 5, 2012|
|Start Date ICMJE||January 2013|
|Estimated Primary Completion Date||December 2013 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01701908 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Postoperative Pulmonary Complications in Abdominal Surgery|
|Official Title ICMJE||Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study|
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.
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 patient's 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 general anesthesia for major abdominal surgery (general surgery, urology, gynecology).
Respiratory complications are: pneumonia, respiratory insufficiency 8,9, pleural effusion, pneumothorax, atelectasia, ab ingestis pneumonia, necessity of oxygen supply, non invasive mechanical ventilation (NIMV) or tracheal reintubation.
SECONDARY END POINTS
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) 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).
Patient's 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 (assisted/mechanical) will be noted in the CRF.
Antibiotic therapy and any pathogen responsible for pneumonia will be noted on 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 patient's 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.
A form divided in three sections (pre/intra/postoperative 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 will be performed with this timing:
after the 15 days enrolment period; after 4 months from the beginning of the study (30 days postoperative follow up); after 6 months from the beginning of the study (60 days postoperative follow up); after 16 months from the beginning of the study (1 year postoperative follow up) Every center will store its own paper CRF.
In the preoperative section will be recorded the patient's 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 (number of cigarettes), ex-smoker or not smoker; history of alcohol abuse (active potus, previous or abstinent); active cancer (excluding the diagnosis for surgery); SpO2, PaO2, PaO2/FiO2, 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 patient's 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, mL/Kg/h); type of ventilation (PCV/VCV); ventilation parameters (TV, Pins, PEEP, RR, FiO2); recruitment maneuvers (yes/no) (manuals, pressure controlled); intraoperative ventilatory problems ( (SpO2 < 90%, PaO2/FiO2 < 300, PaCO2 > 45 mmHg, increase of airways pressure over than 30 cmH2O, bronchospasm, needs of TV> 10 mL/Kg); hemorrhage or need of blood products transfusion; cardiovascular problems (hypotension, tachycardia, bradycardia, arrhythmia) and use of cardio/vasoactive drugs;
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;
Investigators are going to enroll 1500 patients undergoing elective major abdominal surgery, in a period of 15 days. Investigator decided to enroll all the patients in a limited period of time (as in LAS VEGAS [for more information...see www.euroanaesthesia.org., European Society of Anesthesiology (ESA) Clinical Trial Network]) and, if the sample size will not be sufficient, it will be possible to add 15 extra days. On the basis of works published by Squadrone et. al. (16%), Lawrence et.al.  (4,5%), Hall et. al.  (15%), Mitchell et.al.  (11%) and Canet et. al. (7,2%) , the hypothesis was that the incidence of primary outcome (PaO2 /FiO2≤ 300) will be 7%.
The sample size has been calculated using alpha = 0,05 (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:
The data will be saved on an electronic support, using the Softwares Epi info 2002 (CDC), SPSS11.0 (SPSS) and STATA 9.0 (STATA), when appropriate.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia.
|Condition ICMJE||Postoperative Pulmonary Complications|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||1500|
|Completion Date||Not Provided|
|Estimated Primary Completion Date||December 2013 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Italy|
|NCT Number ICMJE||NCT01701908|
|Other Study ID Numbers ICMJE||PPC2012|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Giorgio Della Rocca, University of Udine|
|Study Sponsor ICMJE||University of Udine|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Udine|
|Verification Date||October 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP