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Postoperative Pulmonary Complications in Abdominal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University of Udine.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, University of Udine
ClinicalTrials.gov Identifier:
NCT01701908
First received: September 30, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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.


Condition
Postoperative Pulmonary Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study

Further study details as provided by University of Udine:

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Hide Detailed Description

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 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

To determine:

  • postoperative incidence of necessity of tracheal reintubation
  • duration of mechanical ventilatory support
  • postoperative incidence of infections
  • postoperative incidence of PostOperative Residual Curarization (PORC)
  • postoperative incidence of cardiovascular complications
  • postoperative outcome (30, 60 days and one year later)
  • time of hospital stay, hospital mortality
  • necessity of admission to ICU and ICU length of stay

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.

DATA COLLECTION:

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;

  • 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. 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.[11] (16%), Lawrence et.al. [17] (4,5%), Hall et. al. [18] (15%), Mitchell et.al. [19] (11%) and Canet et. al. (7,2%) [10], 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:

  • 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, using the Softwares Epi info 2002 (CDC), SPSS11.0 (SPSS) and STATA 9.0 (STATA), when appropriate.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia.
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years
  • Ability to provide informed consent
  • Elective surgery
  • Laparotomic or laparoscopic major abdominal surgery
  • Major urological surgery (performed under general anesthesia)
  • Major gynecological surgery (performed under general anesthesia)

Exclusion Criteria:

  • Patients undergoing urgent or emergent surgery
  • Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery
  • Patients with chronic neuro-muscular junction disorders
  • Immunocompromised or immunodepressed patients
  • Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)
  • Patients with preoperative mechanical ventilation
  • Patients with preoperative SpO2 <90%, PaO2 <60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio <300, or PaCO2 >45 mmHg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701908

Locations
Italy
Desenzano Hospital
Desenzano del Garda, Brescia, Italy, 25015
C.E.S.A.T. S. Pietro Igneo Hospital
Fucecchio, Firenze, Italy, 50054
San Gerardo Hospital
Monza, Monza e Brianza, Italy, 20900
Ceccarini Hospital
Riccione, Rimini, Italy, 47838
Institute For Cancer Research And Treatment
Candiolo, Torino, Italy, 10060
S.Luigi Gonzaga Hospital
Orbassano, Torino, Italy, 10043
S. Valentino Hospital
Montebelluna, Treviso, Italy, 31044
Department of Anesthesia and Intensive Care Medicine of the Medical School of the University of Udine (Coordinating center)
Udine, UD, Italy, 33100
Orlandi Hospital
Bussolengo, Verona, Italy, 37012
Italian National Research Centres On Aging
Ancona, Italy
Cardinal Massaia Hospital
Asti, Italy, 14100
Bari Hospital
Bari, Italy, 70131
S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Catania Hospital (Policlinico)
Catania, Italy, 95123
Cannizzaro Emergency Hospital
Catania, Italy, 95126
S. Anna Hospital
Ferrara, Italy, 44124
Mugello Hospital
Firenze, Italy, 50122
S. Maria Nuova Hospital
Firenze, Italy, 50123
Careggi Hospital
Firenze, Italy, 50134
IRCCS San Martino
Genova, Italy, 16132
Fazzi Hospital
Lecce, Italy, 73100
Macerata Hospital
Macerata, Italy, 62100
Mantova Hospital
Mantova, Italy, 46100
IRCCS S. Raffaele, Milano
Milano, Italy, 20132
European Institute Of Oncology
Milano, Italy, 20141
San Paolo Hospital, University Of Milano
Milano, Italy, 20142
Niguarda Ca' Granda, Milano
Milano, Italy, 20162
Federico II Hospital
Napoli, Italy, 80131
Major Charity Hospital
Novara, Italy, 28100
IRCCS San Matteo Hospital
Pavia, Italy, 27100
S.Maria of Mercy Hospital
Perugia, Italy, 06156
Nuovo Santa Chiara Hospital
Pisa, Italy, 56100
Prato Hospital
Prato, Italy, 59100
Umberto I, "Sapienza", University of Rome
Rome, Italy, 00161
Catholic University Hospital A. Gemelli
Rome, Italy, 00168
San Giovanni Battista Hospital
Torino, Italy, 10126
S.Maria di Ca' Foncello
Treviso, Italy, 31100
Sponsors and Collaborators
University of Udine
Investigators
Principal Investigator: Giorgio Della Rocca, Professor University of Udine
  More Information

Publications:

Responsible Party: Giorgio Della Rocca, MD, Principal Investigator, University of Udine
ClinicalTrials.gov Identifier: NCT01701908     History of Changes
Other Study ID Numbers: PPC2012 
Study First Received: September 30, 2012
Last Updated: October 5, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Udine:
PPCs
abdominal surgery
postoperative infections
postoperative residual curarization
tracheal re-intubation
mortality
ICU stay

ClinicalTrials.gov processed this record on December 09, 2016