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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

Related publications:

Smetana GW. Preoperative pulmonary evaluation. N Engl J Med. 1999 Mar 25;340(12):937-44. Review.

Smetana GW, Lawrence VA, Cornell JE; American College of Physicians. Preoperative pulmonary risk stratification for noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):581-95. Review.

Fleischmann KE, Goldman L, Young B, Lee TH. Association between cardiac and noncardiac complications in patients undergoing noncardiac surgery: outcomes and effects on length of stay. Am J Med. 2003 Nov;115(7):515-20.

Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3.

Fisher BW, Majumdar SR, McAlister FA. Predicting pulmonary complications after nonthoracic surgery: a systematic review of blinded studies. Am J Med. 2002 Feb 15;112(3):219-25. Review.

Antonelli M, Conti G, Bufi M, Costa MG, Lappa A, Rocco M, Gasparetto A, Meduri GU. Noninvasive ventilation for treatment of acute respiratory failure in patients undergoing solid organ transplantation: a randomized trial. JAMA. 2000 Jan 12;283(2):235-41.

Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. Epub 2005 Nov 8.

Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71.

Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93.

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

Dimick JB, Pronovost PJ, Cowan JA Jr, Lipsett PA, Stanley JC, Upchurch GR Jr. Variation in postoperative complication rates after high-risk surgery in the United States. Surgery. 2003 Oct;134(4):534-40; discussion 540-1.

McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. Epub 2004 Nov 24.

Gupta H, Gupta PK, Fang X, Miller WJ, Cemaj S, Forse RA, Morrow LE. Development and validation of a risk calculator predicting postoperative respiratory failure. Chest. 2011 Nov;140(5):1207-15. doi: 10.1378/chest.11-0466. Epub 2011 Jul 14.

Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. Review.

Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95.

Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50.

Hall JC, Tarala RA, Hall JL. Respiratory insufficiency after abdominal surgery. Respirology. 1996 Jun;1(2):133-8.

Mitchell CK, Smoger SH, Pfeifer MP, Vogel RL, Pandit MK, Donnelly PJ, Garrison RN, Rothschild MA. Multivariate analysis of factors associated with postoperative pulmonary complications following general elective surgery. Arch Surg. 1998 Feb;133(2):194-8.

Starting date: January 2013
Last updated: October 5, 2012

Page last updated: August 20, 2015

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