Postoperative Pulmonary Complications in Abdominal Surgery
Information source: University of Udine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pulmonary Complications
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Udine Official(s) and/or principal investigator(s): Giorgio Della Rocca, Professor, Principal Investigator, Affiliation: University of Udine
Overall contact: Giorgio Della Rocca, Professor, Phone: +39 0432 559501, Email: giorgio.dellarocca@uniud.it
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.
Clinical Details
Official title: Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Giorgio Della Rocca, Professor, Phone: +39 0432 559501, Email: giorgio.dellarocca@uniud.it
Italian National Research Centres On Aging, Ancona, Italy; Not yet recruiting Gabriella Bettelli, Email: g.bettelli@inrca.it Gabriella Bettelli, MD, Principal Investigator
Cardinal Massaia Hospital, Asti 14100, Italy; Not yet recruiting Agostino Roasio, Email: aroasio@asl.at.it Agostino Roasio, MD, Principal Investigator
Bari Hospital, Bari 70131, Italy; Not yet recruiting Salvatore Grasso, Email: sgrasso@rianima.uniba.it Salvatore Grasso, MD, Principal Investigator
S.Orsola-Malpighi Hospital, Bologna 40138, Italy; Not yet recruiting Maurizio Fusari, Email: maurizio.fusari@fastwebnet.it Maurizio Fusari, MD, Principal Investigator
Cannizzaro Emergency Hospital, Catania 95126, Italy; Not yet recruiting Luigi Vicari, Email: mednemo@gmail.com Luigi Vicari, MD, Principal Investigator
Catania Hospital (Policlinico), Catania 95123, Italy; Not yet recruiting Antonino Gullo, Email: a.gullo@policlinico.unict.it Antonino Gullo, MD, Principal Investigator
S. Anna Hospital, Ferrara 44124, Italy; Not yet recruiting Teresa Matarazzo, Email: t.matarazzo@ospfe.it Teresa Matarazzo, MD, Principal Investigator
Careggi Hospital, Firenze 50134, Italy; Not yet recruiting Raffaele De Gaudio, Email: rdegaudio@tin.it Raffaele De Gaudio, MD, Principal Investigator
Mugello Hospital, Firenze 50122, Italy; Not yet recruiting Vieri Parrini, Email: vieri.parrini@asf.toscana.it Vieri Parrini, MD, Principal Investigator
S. Maria Nuova Hospital, Firenze 50123, Italy; Not yet recruiting Antonio Franco, Email: antonio.franco@asf.toscana.it Antonio Franco, MD, Principal Investigator
IRCCS San Martino, Genova 16132, Italy; Not yet recruiting Luigi Spagnolo, Email: luigispagnolo1@yahoo.it Luigi Spagnolo, MD, Principal Investigator
Fazzi Hospital, Lecce 73100, Italy; Not yet recruiting Luigi Fuggiano, Email: luigifuggiano@gmail.com Luigi Fuggiano, MD, Principal Investigator
Macerata Hospital, Macerata 62100, Italy; Not yet recruiting Giuseppe Tappata, Email: giuseppe.tappatà@sanita.marche.it Giuseppe Tappata, MD, Principal Investigator
Mantova Hospital, Mantova 46100, Italy; Not yet recruiting Vincenzo Sgarioto, Email: vincenzo.sgarioto@aopoma.it Vincenzo Sgarioto, MD, Principal Investigator
European Institute Of Oncology, Milano 20141, Italy; Not yet recruiting Daniele Sances, Email: daniele.sances@ieo.it Daniele Sances, MD, Principal Investigator
IRCCS S. Raffaele, Milano, Milano 20132, Italy; Not yet recruiting Elena Bignami, MD, Email: bignami.elena@hsr.it Elena Bignami, MD, Principal Investigator Giacomo Moniti, MD, Sub-Investigator
Niguarda Ca' Granda, Milano, Milano 20162, Italy; Not yet recruiting Ines Arpino, Email: inesarpino@hotmail.com Ines Arpino, MD, Principal Investigator
San Paolo Hospital, University Of Milano, Milano 20142, Italy; Not yet recruiting Concezione Tommasino, Email: concezione.tommasino@unimi.it Tommasino Concezione, MD, Principal Investigator
Federico II Hospital, Napoli 80131, Italy; Not yet recruiting Rosalba Tufano, Email: rtufano@unina.it Rosalba Tufano, MD, Principal Investigator
Major Charity Hospital, Novara 28100, Italy; Not yet recruiting Valeria Viarengo, Email: valeria.viarengo@maggioreosp.novara.it Valeria Viarengo, MD, Principal Investigator
IRCCS San Matteo Hospital, Pavia 27100, Italy; Not yet recruiting Antonio Braschi, Email: antonio.braschi@unipv.it Antonio Braschi, MD, Principal Investigator
S.Maria of Mercy Hospital, Perugia 06156, Italy; Not yet recruiting Paola Fabbricini, Email: paola.fabbriccini@unipg.it Paola Fabbricini, MD, Principal Investigator
Nuovo Santa Chiara Hospital, Pisa 56100, Italy; Not yet recruiting Francesco Forfori, Email: forforiden@libero.it Francesco Forfori, MD, Principal Investigator
Prato Hospital, Prato 59100, Italy; Not yet recruiting Guglielmo Consales, Email: gconsales@gmail.com Guglielmo Consales, MD, Principal Investigator
Catholic University Hospital A. Gemelli, Rome 00168, Italy; Not yet recruiting Paolo Primieri, Email: p.primieri@libero.it Paolo Primieri, MD, Principal Investigator
Umberto I, "Sapienza", University of Rome, Rome 00161, Italy; Not yet recruiting Franco Ruberto, Email: rube2005@libero.it Franco Ruberto, MD, Principal Investigator Maurizio Marandola, MD, Sub-Investigator Sergio Gazzanelli, MD, Sub-Investigator Di Marco Pierangelo, MD, Sub-Investigator
San Giovanni Battista Hospital, Torino 10126, Italy; Not yet recruiting Elisabetta Cerutti, Email: ecerutti@molinette.piemonte.it Elisabetta Cerutti, MD, Principal Investigator
S.Maria di Ca' Foncello, Treviso 31100, Italy; Not yet recruiting Roberto Nani, Email: rnani@ulss.tv.it Roberto Nani, MD, Principal Investigator
Desenzano Hospital, Desenzano del Garda, Brescia 25015, Italy; Not yet recruiting Nicola Petrucci, Email: ni.petrucci@tiscali.it Nicola Petrucci, MD, Principal Investigator
C.E.S.A.T. S. Pietro Igneo Hospital, Fucecchio, Firenze 50054, Italy; Not yet recruiting Emanuele Mori, Email: emanuele.mori@gmail.com Emanuele Mori, MD, Principal Investigator
San Gerardo Hospital, Monza, Monza e Brianza 20900, Italy; Not yet recruiting Roberto Fumagalli, Email: r.fumagalli@hsgerardo.org Roberto Fumagalli, MD, Principal Investigator
Ceccarini Hospital, Riccione, Rimini 47838, Italy; Not yet recruiting Alessandro Gatta, Email: alessandrogatta@gmail.com Alessandro Gatta, MD, Principal Investigator
Institute For Cancer Research And Treatment, Candiolo, Torino 10060, Italy; Not yet recruiting Francesco Bona, Email: mantis96@gmail.com Francesco Bona, MD, Principal Investigator
S.Luigi Gonzaga Hospital, Orbassano, Torino 10043, Italy; Not yet recruiting Augusto Tempia, Email: augusto.tempia@unito.it Augusto Tempia, MD, Principal Investigator
S. Valentino Hospital, Montebelluna, Treviso 31044, Italy
Department of Anesthesia and Intensive Care Medicine of the Medical School of the University of Udine (Coordinating center), Udine, UD 33100, Italy; Not yet recruiting Giorgio Della Rocca, Professor, Phone: +39 0432 559501, Email: giorgio.dellarocca@uniud.it Giorgio Della Rocca, MD, Professor, PI, Principal Investigator
Orlandi Hospital, Bussolengo, Verona 37012, Italy; Not yet recruiting Plinio Calligaro, Email: pcalligaro@ulss22.ven.it Plinio Calligaro, MD, Principal Investigator
Additional Information
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Starting date: January 2013
Last updated: October 5, 2012
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