Postoperative Pulmonary Complications in Major Abdominal Surgery

NCT01701908 | Completed DMC

• 1 other identifier: PPC01
• Study Type: observational
• Target: 1,542
• Locations: 1 country
• Sites: 40

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.

Conditions

Postoperative Pulmonary Complications

Keywords

PPCs; abdominal surgery; postoperative infections; postoperative residual curarization; tracheal re-intubation; mortality; ICU stay

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications rate

  Complications are: respiratory infection, postoperative respiratory failure, pleural effusion, pneumothorax, atelectasis, aspiration pneumonia, bronchospasm, need of oxygen supplementation or noninvasive ventilatory support or unplanned urgent re-intubation

  From surgery to hospital discharge (an average of 10 days)

Secondary Outcomes (9)

• Postoperative pulmonary complications rate in general, gynecology and urology

  From surgery to hospital discharge (an average of 10 days)

• Mortality rate after surgery

  Up to 1 year after surgery

• Length of hospital stay

  From surgery to hospital discharge (an average of 10 days)

• Unplanned postoperative Intensive care unit (ICU) admission

  From surgery to hospital discharge (an average of 10 days)

• Intensive care unit length of stay

  From surgery to hospital discharge (an average of 10 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Udine: lead

Study Sites (40)

Ospedale Grassi

Ostia Antica, Rome, Italy

Location

Istituto di Candiolo

Candiolo, Torino, 10060, Italy

Location

S. Valentino Hospital

Montebelluna, Treviso, 31044, Italy

Location

AO Santa Maria della Misericordia

Udine, UD, 33100, Italy

Location

University of Verona

Bussolengo, Verona, 37012, Italy

Location

Ospedali Riuniti

Ancona, Italy

Location

Cardinal Massaia Hospital

Asti, 14100, Italy

Location

Irccs Cro

Aviano, Italy

Location

Policlinico di Bari Ospedale Giovanni XXIII

Bari, 70131, Italy

Location

Ospedale Rummo

Benevento, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Italy

Location

S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Spedali Civili

Brescia, Italy

Location

Ospedale Versilia

Camaiore, Italy

Location

ASST Lariana

Como, Italy

Location

ASST Cremona

Cremona, Italy

Location

ASO S Croce e Carle

Cuneo, Italy

Location

Azienda Ospedaliero-Universitaria

Ferrara, 44124, Italy

Location

Mugello Hospital

Florence, 50122, Italy

Location

S. Maria Nuova Hospital

Florence, 50123, Italy

Location

University of Foggia

Foggia, Italy

Location

Presidio Ospedaliero Sora

Frosinone, Italy

Location

IRCCS San Martino

Genova, 16132, Italy

Location

Fazzi Hospital

Lecce, 73100, Italy

Location

Ospedale Provinciale di Macerata

Macerata, 62100, Italy

Location

IRCCS Fondazione Istituto Nazionale dei Tumori

Milan, Italy

Location

IRCCS S. Raffaele, Milano

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Vanvitelli

Naples, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy

Location

Ospedale Monaldi

Naples, Italy

Location

Federico II Hospital

Napoli, 80131, Italy

Location

Nuovo Santa Chiara Hospital

Pisa, 56100, Italy

Location

Irccs Cro

Potenza, Italy

Location

Azienda USL IRCCS

Reggio Emilia, Italy

Location

Umberto I, "Sapienza", University of Rome

Rome, 00161, Italy

Location

Catholic University Hospital A. Gemelli

Rome, 00168, Italy

Location

Campus Bio-medico Foundation

Rome, Italy

Location

Università Cattolica del Sacro Cuore

Rome, Italy

Location

Ospedale S Chiara

Trento, Italy

Location

OC San Bortolo

Vicenza, Italy

Location

Related Publications (19)

• Smetana GW. Preoperative pulmonary evaluation. N Engl J Med. 1999 Mar 25;340(12):937-44. doi: 10.1056/NEJM199903253401207. No abstract available.

  PMID: 10089188 BACKGROUND

• 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. doi: 10.7326/0003-4819-144-8-200604180-00009.

  PMID: 16618956 BACKGROUND

• 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. doi: 10.1016/s0002-9343(03)00474-1.

  PMID: 14599629 BACKGROUND

• 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. doi: 10.1097/01.sla.0000179621.33268.83.

  PMID: 16135919 BACKGROUND

• 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. doi: 10.1016/s0002-9343(01)01082-8.

  PMID: 11893349 BACKGROUND

• 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. doi: 10.1001/jama.283.2.235.

  PMID: 10634340 BACKGROUND

• 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. doi: 10.1186/cc3887. Epub 2005 Nov 8.

  PMID: 16356219 BACKGROUND

• Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997 Mar;111(3):564-71. doi: 10.1378/chest.111.3.564.

  PMID: 9118688 BACKGROUND

• 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. doi: 10.1056/NEJMoa022450.

  PMID: 12594312 BACKGROUND

• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate 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.

  PMID: 21045639 BACKGROUND

• 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.

  PMID: 22998715 BACKGROUND

• 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. doi: 10.1016/s0039-6060(03)00273-3.

  PMID: 14605612 BACKGROUND

• 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. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.

  PMID: 15563632 BACKGROUND

• 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):1207-1215. doi: 10.1378/chest.11-0466. Epub 2011 Jul 14.

  PMID: 21757571 BACKGROUND

• Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. doi: 10.1056/NEJM200005043421806. No abstract available.

  PMID: 10793167 BACKGROUND

• 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. doi: 10.1001/jama.293.5.589.

  PMID: 15687314 BACKGROUND

• Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50. doi: 10.1378/chest.110.3.744.

  PMID: 8797421 BACKGROUND

• Hall JC, Tarala RA, Hall JL. Respiratory insufficiency after abdominal surgery. Respirology. 1996 Jun;1(2):133-8. doi: 10.1111/j.1440-1843.1996.tb00022.x.

  PMID: 9434329 BACKGROUND

• 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. doi: 10.1001/archsurg.133.2.194.

  PMID: 9484734 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giorgio Della Rocca, Professor

  University of Udine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: September 30, 2012
• First Posted: October 5, 2012
• Study Start: April 17, 2013
• Primary Completion: June 5, 2014
• Study Completion: June 8, 2015
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

IT (40)