Postoperative Pulmonary Complications in Major Abdominal Surgery

November 22, 2022 updated by: Giorgio Della Rocca, University of Udine

Postoperative Pulmonary Complications in Major Abdominal Surgery: a Multicenter Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

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 elective general anesthesia for major abdominal surgery (general surgery, urology, gynecology).

Respiratory complications are: pneumonia, respiratory insufficiency, pleural effusion, pneumothorax, atelectasis, ab ingestis pneumonia, necessity of oxygen supply, non invasive mechanical ventilation (NIMV) or tracheal reintubation.

SECONDARY END POINTS

To determine:

  • postoperative pulmonary complications rate in general, gynecology and urology
  • length of hospital stay
  • unplanned postoperative Intensive care unit (ICU) admission and ICU length of stay
  • postoperative incidence of tracheal reintubation
  • postoperative incidence of infections
  • postoperative incidence of PostOperative Residual Curarization (PORC)
  • postoperative incidence of cardiovascular complications
  • postoperative mortality (in-hospital, 30, 60 days and one year later)

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 and on the day of hospital discharge) 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..

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.

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; history of alcohol abuse; 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. 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 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 and analyzed with SPSS.

Study Type

Observational

Enrollment (Actual)

1542

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Ospedali Riuniti
      • Asti, Italy, 14100
        • Cardinal Massaia Hospital
      • Aviano, Italy
        • Irccs Cro
      • Bari, Italy, 70131
        • Policlinico di Bari Ospedale Giovanni XXIII
      • Benevento, Italy
        • Ospedale Rummo
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • S.Orsola-Malpighi Hospital
      • Brescia, Italy
        • Spedali Civili
      • Camaiore, Italy
        • Ospedale Versilia
      • Como, Italy
        • Asst Lariana
      • Cremona, Italy
        • ASST Cremona
      • Cuneo, Italy
        • ASO S Croce e Carle
      • Ferrara, Italy, 44124
        • Azienda Ospedaliero-Universitaria
      • Firenze, Italy, 50122
        • Mugello Hospital
      • Firenze, Italy, 50123
        • S. Maria Nuova Hospital
      • Foggia, Italy
        • University of Foggia
      • Frosinone, Italy
        • Presidio Ospedaliero Sora
      • Genova, Italy, 16132
        • IRCCS San Martino
      • Lecce, Italy, 73100
        • Fazzi Hospital
      • Macerata, Italy, 62100
        • Ospedale Provinciale di Macerata
      • Milan, Italy
        • IRCCS Fondazione Istituto Nazionale dei Tumori
      • Milano, Italy, 20132
        • IRCCS S. Raffaele, Milano
      • Naples, Italy
        • Azienda Ospedaliero Universitaria Vanvitelli
      • Naples, Italy
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Naples, Italy
        • Ospedale Monaldi
      • Napoli, Italy, 80131
        • Federico II Hospital
      • Pisa, Italy, 56100
        • Nuovo Santa Chiara Hospital
      • Potenza, Italy
        • Irccs Cro
      • Reggio Emilia, Italy
        • Azienda USL IRCCS
      • Rome, Italy, 00161
        • Umberto I, "Sapienza", University of Rome
      • Rome, Italy, 00168
        • Catholic University Hospital A. Gemelli
      • Rome, Italy
        • Campus Bio-medico Foundation
      • Rome, Italy
        • Universita Cattolica del Sacro Cuore
      • Trento, Italy
        • Ospedale S Chiara
      • Vicenza, Italy
        • OC San Bortolo
    • Rome
      • Ostia, Rome, Italy
        • Ospedale Grassi
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Istituto di Candiolo
    • Treviso
      • Montebelluna, Treviso, Italy, 31044
        • S. Valentino Hospital
    • UD
      • Udine, UD, Italy, 33100
        • AO Santa Maria della Misericordia
    • Verona
      • Bussolengo, Verona, Italy, 37012
        • University of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications rate
Time Frame: From surgery to hospital discharge (an average of 10 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications rate in general, gynecology and urology
Time Frame: From surgery to hospital discharge (an average of 10 days)
Pulmonary complications among different type of surgery
From surgery to hospital discharge (an average of 10 days)
Mortality rate after surgery
Time Frame: Up to 1 year after surgery
Incidence of mortality after surgery in patients with or without postoperative pulmonary complications
Up to 1 year after surgery
Length of hospital stay
Time Frame: From surgery to hospital discharge (an average of 10 days)
Duration of hospital stay after surgery
From surgery to hospital discharge (an average of 10 days)
Unplanned postoperative Intensive care unit (ICU) admission
Time Frame: From surgery to hospital discharge (an average of 10 days)
Unplanned ICU admission after surgery
From surgery to hospital discharge (an average of 10 days)
Intensive care unit length of stay
Time Frame: From surgery to hospital discharge (an average of 10 days)
Duration of ICU stay
From surgery to hospital discharge (an average of 10 days)
Postoperative incidence of tracheal re-intubation
Time Frame: From surgery to hospital discharge (an average of 10 days)
Re-intubation rate after discharge from the operating room or after ICU discharge
From surgery to hospital discharge (an average of 10 days)
Postoperative incidence of infections
Time Frame: From surgery to hospital discharge (an average of 10 days)
Occurrence of pneumonia, surgical site infection and any other infections
From surgery to hospital discharge (an average of 10 days)
Postoperative incidence of cardiovascular complications
Time Frame: From surgery to hospital discharge (an average of 10 days)
Cardiovascular complications: arrhythmias, acute coronary syndrome, mycardial infarction, acute congestive heart failure
From surgery to hospital discharge (an average of 10 days)
Postoperative incidence of PostOperative Residual Curarization (PORC)
Time Frame: Up to 3 hours after extubation
PORC defined as: train-of-four ratio < 0.9 after extubation or need for reversal drug fo neuromuscular blocking agent after extubation
Up to 3 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Udine

Investigators

  • Principal Investigator: Giorgio Della Rocca, Professor, University of Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2013

Primary Completion (Actual)

June 5, 2014

Study Completion (Actual)

June 8, 2015

Study Registration Dates

First Submitted

September 30, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PPC01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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