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Postoperative Pulmonary Complications in Major Abdominal Surgery (PPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Azienda Ospedaliera S. Maria della Misericordia
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier:
NCT01914328
First received: July 8, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the incidence of pulmonary complications in patients undergone major abdominal elective surgery performed under general anesthesia.


Condition
Postoperative Respiratory Complications
Postoperative Complications
Surgical Site Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Pulmonary Complications in Major Abdominal Surgery: Prospective Observational Multicentric Study

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera S. Maria della Misericordia:

Primary Outcome Measures:
  • The primary aim of the study is to evaluate the incidence of postoperative pulmonary complications (PPC) in patients undergoing major abdominal surgery. [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]

    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.

    Respiratory infection is defined as appearance of a new infiltrate on chest radiograph combined with at least two of the following criteria: body temperature greater than 38°C or less than 35.5°C, white blood cell count greater than 12000/mm3 or smaller than 4000/mm3, presence of purulent sputum.Respiratory failure is defined as a postoperative oxygen saturation by pulse oximetry (SpO2) less than 90%, or a PaO2/FiO2 ratio less than 300, a partial arterial pressure of carbon dioxide (PaCO2) greater than 45 mmHg, onset of dyspnea with respiratory distress and/or use of accessory muscles of respiration. The pleural effusion is identified as an opacity at the chest radiograph that was not present in previous radiographs or ultrasound



Secondary Outcome Measures:
  • The secondary aim of the study is to define the length of hospitalization in patients undergoing major abdominal surgery. [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]
    Length of hospitalization is defined as the time spent from the day of surgery to the day of hospital discharge

  • The secondary aim of the study is to define the incidence of mortality in patients undergoing major abdominal surgery [ Time Frame: 5 Weeks after surgery, 60 days and 1 year after discharge ] [ Designated as safety issue: No ]
  • Incidence of postoperative surgical infections [ Time Frame: 5 Weeks after surgery, 30-60 days after discharge ] [ Designated as safety issue: No ]
    Surgical infections are defined as an infection of the surgical site or directly connected to the surgical procedure

  • Incidence of cardiovascular complications [ Time Frame: 5 Weeks after surgery, 30, 60 days, 1 year after discharge ] [ Designated as safety issue: No ]
    Cardiovascular complications are defined as arrhythmias, acute coronary syndrome, myocardial failure, angina pectoris.

  • Incidence of postoperative residual curarization [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]

    Symptoms related to postoperative residual curarization are:

    evident muscle fatigue or 'fade' due to continuing occupation of presynaptic receptors by molecules of curare

    attenuation of the hypoxic reflex due to the inhibition of functional nicotinic cholinergic receptors of the carotid glomus

    pharyngolaryngeal dysfunction with loss of airway patency and the risk of "aspiration".

    Reduction of the cough reflex, and reduced expansion of the rib cage, with superficial ventilation and often inadequate and decreased clearance of tracheobronchial secretions


  • Duration of ventilatory support [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]
  • Incidence of Re-Intubation [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]
  • Incidence of ICU admission [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]
  • Incidence of ICU length of stay [ Time Frame: 5 Weeks after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: June 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Patients Undergoing Major Abdominal Surgery Performed under General Anesthesia

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 who needed mechanical ventilation in the last 30 days
  • 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: NCT01914328

Contacts
Contact: Giorgio Della Rocca, MD, Prof +390432559901 giorgio.dellarocca@uniud.it
Contact: Lorenzo Spagnesi, MD +390432559909 lorspain@libero.it

Locations
Italy
AO Benevento Not yet recruiting
Benevento, BN, Italy
Contact: Guido Prizio         
Ospedale Bologna Not yet recruiting
Bologna, BO, Italy
Contact: Rocco D'Andrea         
Sant'Orsola Bologna Not yet recruiting
Bologna, BO, Italy
Contact: Maria Pia Rinaldi         
Contact: Cristina Laici         
Ospedali Civili Not yet recruiting
Brescia, BS, Italy
Contact: Arturo Toninelli         
AOS S.Croce e Carle Not yet recruiting
Cuneo, CN, Italy
Contact: Giuseppe Cornara         
Sant'Anna di San Fermo Not yet recruiting
Como, CO, Italy
Contact: Rinaldo Grasso         
Ospedale Cremona Not yet recruiting
Cremona, CR, Italy
Contact: Danelli Giorgio         
Principal Investigator: Giorgio Danelli         
Università degli studi di Ferrara Not yet recruiting
Ferrara, FE, Italy
Contact: Savino Spadaro         
AOU Foggia Not yet recruiting
Foggia, FG, Italy
Contact: Lucia Mirabella         
Ospedale S. Maria Nuova Recruiting
Firenze, FI, Italy
Contact: Antonio Franco         
Ospedala Macerata Not yet recruiting
Macerata, MC, Italy
Contact: Emanuele Iacobone         
IRCCS Istituto Nazionale Tumori Not yet recruiting
Milano, MI, Italy
Contact: Federico Piccioni         
Ospedale San Raffaele Recruiting
Milano, MI, Italy
Contact: Elena Bignami         
Principal Investigator: Elena Bignami         
IRCCS Not yet recruiting
Sesto San Giovanni, MI, Italy
Contact: Massimiliano Nuzzi         
Ospedale Cisanello Pisa Not yet recruiting
Pisa, PI, Italy
Contact: Federico Piccioni         
CRO Not yet recruiting
Aviano, PN, Italy
Contact: Fabio Fabiani         
AO Grassi Not yet recruiting
Ostia, RM, Italy
Contact: Carmen Santagata         
A.Gemelli Università Cattolica Recruiting
Roma, RM, Italy
Contact: Liliana Sollazzi         
Contact: Andrea Arcangeli         
Sub-Investigator: Germano De Cosmo         
Campus Biomedico Recruiting
Roma, RM, Italy
Contact: Serena Antonelli         
Umberto I, Università Sapienza Not yet recruiting
Roma, RM, Italy
Contact: Pierangelo Di Marco         
Contact: Franco Ruberto         
Sub-Investigator: Carmen D'Arena         
Sub-Investigator: Paola Congi         
Sub-Investigator: Sergio Gazzanelli         
Ospedale Savona Not yet recruiting
Savona, SV, Italy
Contact: Walter Belcio         
Ospedale di Trento Not yet recruiting
Trento, TN, Italy
Contact: Paolo Bettonte         
IRCC Candiolo Not yet recruiting
Torino, TO, Italy
Contact: Edoardo Zocca         
Contact: Gianmarco Giacoletto         
Ospedale Montebelluna Not yet recruiting
Montebelluna, TV, Italy
Contact: Andrea Bianchin         
USSL 9 Veneto Not yet recruiting
Treviso, TV, Italy
Contact: Mirka Fabbris         
Contact: Sandro Pavan         
AOU Recruiting
Udine, UD, Italy, 33100
Contact: Giorgio Della Rocca, Prof, MD    +390432559901    giorgio.dellarocca@uniud.it   
Contact: Lorenzo Spagnesi, MD    +390432559901    lorenzo.spagnesi@aoud.sanita.fvg.it   
Principal Investigator: Giorgio Della Rocca, Prof         
Sub-Investigator: Lorenzo Spagnesi, MD         
Ospedale Civile Vicenza Not yet recruiting
Vicenza, VI, Italy
Contact: Marco Irone         
Ospedale Monaldi Not yet recruiting
Napoli, Italy
Contact: Clelia Esposito         
Principal Investigator: Clelia Esposito         
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia
Investigators
Principal Investigator: Giorgio Della Rocca, Prof, MD AOU Udine
  More Information

Additional Information:
No publications provided

Responsible Party: Giorgio Della Rocca, Professor, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT01914328     History of Changes
Other Study ID Numbers: PPC 01
Study First Received: July 8, 2013
Last Updated: July 31, 2013
Health Authority: Italy: National Bioethics Committee

Keywords provided by Azienda Ospedaliera S. Maria della Misericordia:
Postoperative Pulmonary Complications
PORC
Surgical Related Outcome
Surgical Related Mortality
Postoperative ICU length of stay

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014