AUDIT PROTOCOL
FULL TITLE
The Incidence of Postoperative Pneumonia following Major Elective Surgery: a multi-centre, prospective audit
SHORT TITLE
POP audit
CHIEF INVESTIGATORS
Ravinder Vohra, Clinical Lecturer, Academic Department of Surgery
Email:
Version No. 1.01
Date: 14/10/2014
TABLE OF CONTENTS
KEY CONTACTS
Table of Contents
1.0 Protocol Summary
2.0 Abstract
3.0 Introduction
4.0 RATIONALE OF PROPOSED STUDY
5.0 Objectives
6.0 DESIGN AND METHoDS
7.0 AUDIT MEASURES
8.0 data collection
9.0 Definitions
10.0 Statistical analysis
11.0 REFERENCES
12.0 APPENDIX
KEY CONTACTS
Ravinder Vohra, Clinical Lecturer, Academic Department of Surgery, University of Birmingham, Birmingham, UK
Email:
This protocol was developed by the members of West Midlands Research Collaborative
1.0 PROTOCOL SUMMARY
GENERAL INFORMATIONShort Title / POP audit
Full Title / The Incidence of Postoperative Pneumonia following Major Elective Surgery: a multi-centre, prospective audit
Sponsor / University of Birmingham
West Midlands Research Collaboration (www.wmresearch.org.uk)
Chief Investigators / Ravinder Vohra
Website / www.wmresearch.org.uk
Email /
Co-ordinating Centre / University of Birmingham
STUDY INFORMATION
Indication / To investigate the incidence of postoperative pneumonia following major elective surgery
Design / Observational audit
Primary Outcome / Incidence of postoperative pneumonia between postoperative day 2 and discharge using the Centers for Disease Control and Prevention definition
STUDY TIMELINES
Main study period / 17/11/2014 - 01/12/2014
Follow-up duration / 30 days
End of Trial Definition / 2 weeks
Data submission / 02/01/2015
Data analysis / January 2015
Results available / 01/02/2015
2.0 ABSTRACT
Background: Postoperative pneumonia (POP) is thought to be the most common postoperative complication. However, the incidence ranges from 2-70% of patients following major surgery varying with the type of surgery and the definition for POP used. The most robust and well validated is the definition is the Centers for Disease Control and Prevention (CDC) definition of nosocomial pneumonia. It is important to determine the true incidence using pre-existing guidelines as POP is known to increase length of hospital stay by 75%, costs by 50% and have a negative impact on postoperative survival. POP has been recently highlighted as an important complication in the WHO guidelines for Safer Surgery.
Aim: Using the CDC definition, this audit will determine the incidence of POP in a contemporary cohort undergoing major elective surgery
Methods: The audit will be performed over a two-week period. The audit will be performed using a standardised database at each centre. Inclusion criteria will be all >18 year old patients undergoing major (defined as a postoperative hospital stay of >1 day), elective surgery (patients admitted either the day of surgery or the night before) including the following procedures: upper GI, HPB, colorectal, renal, urological and vascular procedures. All elective operations performed between 0800 17th November 2014 and 0759 1st December 2014 will be included.
Audit standard: Incidence of postoperative pneumonia between postoperative day 2 and discharge using the Centers for Disease Control and Prevention definition.
3.0 INTRODUCTION
Why is Postoperative pneumonia important?
Postoperative pneumonia (POP) is the most common postoperative complication. Depending on the type of surgery performed, POP occurs in 9-40% of patients following abdominal surgery with an associated mortality rate of 30-46% [Arozullah, 2001]. In comparison, postoperative symptomatic venous thromboembolism attracts much attention. However, in a similar group of patients following abdominal surgery, the incidence is less than 1% [White, 2003].
Patients undergoing upper abdominal surgery are particularly vulnerable to developing POP with a reported incidence of 36.7% [Hall, 1991; Thompson, 2006]. The incidence of POP increases further when patients undergo combined thoraco-abdominal procedures for oesophageal or gastro-oesophageal junctional (GOJ) cancers. Following an oesophagectomy, the incidence of POP ranges between 34-57% [Avendano, 2002; Hulscher, 2002; Biere, 2012].
These incidences vary with the type of surgery and the definition for POP used. It is important to define the burden of POP using a consistent, validated definition in a contemporary cohort. This is important as POP can increase length of hospital stay by 75%, costs by 50% and have a negative impact on postoperative survival [Dimick, 2004; Kuppusamy, 2011].
A definition of POP
The Centers for Disease Control and Prevention (CDC) has a well validated definition of nosicomial pneumonia which is cited in over 4,500 peer-reviewed publications [Garner, 1988]. It has been used as a definition of POP as postoperative patients following the 2nd postoperative day who meet these criteria:
FOR ANY PATIENT, at least one of the following:
· Fever (>38°C or >100.4°F)
· Leukopenia (<4000 WBC/mm3) or leukocytosis (≥12,000 WBC/mm3)
· For adults ≥70 years old, altered mental status with no other recognized cause
and at least two of the following:
· New onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
· New onset or worsening cough, or dyspnea, or tachypnea
· Rales or bronchial breath sounds
· Worsening gas exchange (e.g., O2 desaturations (e.g., PaO2/FiO2 ≤240) increased oxygen requirements, or increased ventilator demand)
Pathogenesis of POP
The oral cavity and upper digestive tract is colonised by microbial pathogens. In the perioperative period, aspiration of colonized oropharyngeal sections into the lower respiratory tract, leakage of bacteria around the endotracheal tube cuff into the lung and trauma to the lining of the upper airway by endotracheal intubation, are important mechanisms for the development of both POP and ventilator associated pneumonia (VAP) [American Thoracic Society, 2005; Cardeñosa Cendrero, 1999; Chastre, 2002]. Microbial pathogens enter and colonise the lower respiratory tract, with subsequent establishment of infection by overwhelming the host's mechanical, humoral, and cellular defences [American Thoracic Society, 2005].
The oral microflora has been demonstrated to change within the first 48 hours of critical illness from the usual predominance of Streptococci to more potentially harmful and pathogenic microorganisms [American Thoracic Society, 2005]. These microorganisms have been hypothezised to contribute to the development of both VAP and POP [Celis, 1988; American Thoracic Society, 2005].
Aim:
Incidence of postoperative pneumonia between postoperative day 2 and discharge using the CDC definition
4.0 RATIONALE OF PROPOSED AUDIT
The incidence of POP varies with the type of surgery and the definition for POP used. It is important to define and audit the burden of POP using a consistent, validated definition in a contemporary cohort.
5.0 OBJECTIVES
To measure the incidence of POP between postoperative day 2 and discharge using the CDC definition (primary aim)
To measure the differences in other defined 30-day outcomes in patients with and without POP (secondary aim)
6.0 DESIGN AND METHODS
Contemporary, prospective, audit
o Any West Midlands hospital that provides elective major surgery is eligible to enter patients. A named consultant will act as the local principal investigator (PI) and data collection will be completed by a team of local surgical trainees working at that hospital. This study of current practice will be registered and approved by each individual hospital’s clinical audit department.
· Patient Eligibility
o All patients over the age of 18 years who undergo major (defined as a postoperative hospital stay of >1 day) and elective surgery (patients admitted either the day of surgery or the night before).
o Procedures to include: upper GI, HPB, colorectal, renal, urological, and vascular
· Audit phases
o The audit will be performed across eligible centres from 0800 17th November 2014 and 0759 1st December 2014. A guide has been produced for local investigators wishing to include their centre (appendix 1).
7.0 AUDIT MEASURES
POP between postoperative day 2 and discharge using the CDC definition:
FOR ANY PATIENT, at least one of the following:
· Fever (>38°C or >100.4°F)
· Leukopenia (<4000 WBC/mm3) or leukocytosis (≥12,000 WBC/mm3)
· For adults ≥70 years old, altered mental status with no other recognized cause
AND at least two of the following:
· New onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
· New onset or worsening cough, or dyspnea, or tachypnea
· Rales or bronchial breath sounds
· Worsening gas exchange (e.g., O2 desaturations (e.g., PaO2/FiO2 ≤240) increased oxygen requirements, or increased ventilator demand)
8.0 DATA COLLECTION
· Variables to be collected (for definitions refer to Section 9):
Preoperative
1. Date of admission
2. Age
3. Gender
4. BMI
5. ASA
6. Diagnosis of COPD
7. Current smoker
8. Previous cerebral vascular accident
9. Blood urea
10. Long-term or current steroid use
11. Long-term or current PPI or antacids
12. Pre-operative indication
Intraoperative data
13. Operation date
14. Type of operation (upper GI, HPB, colorectal, renal, urological or vascular)
15. Perioperative antibiotics
16. Laparoscopic or open surgery
17. Bowel resection or anastomosis
18. Thoracic cavity entered
19. Type of intubation (LMA, ETT)
20. Duration of Surgery
21. NGT use
Postoperative data
22. Date extubated
23. Immediate postoperative destination
24. Incentive spirometer
25. Documented chest physiotherapy
26. Analgesia use in postoperative day 1 (Epidural, PCA, wound catheters, oral analgesia)
27. Change in analgesia strategy in postoperative day 1
28. Clinical diagnosis of POP (if so, which of the CDC criteria met)
29. Antibiotics (if so, which?)
30. Readmission to ICU
31. Re-intubation
32. Date of discharge
30 day data
33. All-cause 30-day A&E attendance
34. All-cause 30-day readmission
35. Complications
36. Re-interventions and re-imaging
37. Positive blood or sputum culture results
38. 30-day mortality
· Data collection:
o Data will be collected in a Microsoft Excel spreadsheet. It is the responsibility of the local investigators to ensure that the data is password protected and held on local trust computer systems as this will include patient identifiers to facilitate 30-day follow-up data
· Data collection points:
o Each trust/hospital site will need to identify locations where major, elective surgery is performed to ensure full capture of cases during the audit period
o Patient identification: Patients should be identified on a daily basis from the elective operating lists
o Pre-operative data: This will be completed from information collected from patients’ medical records
o Operative data: This should be completed either by or with input from the operating surgeon or the assistant
o Post-operative data: All patients will be followed for 30 days following their operation. The hospital’s electronic or paper records should be checked by the team to identify any re-admissions or re-attendances to either the hospital’s Emergency Department, surgical assessment unit or wards, Local arrangements may include:
§ Reviewing the patient or patient’s notes during admission to identify inpatient complications.
§ Check the discharge summary or letter to check for any post-operative complications.
§ Check for any outpatient attendances within 30 days of surgery
§ Check electronic or paper hospital records or hand-over lists for re-attendances or re-admissions
§ Check for any A&E re-attendances
§ Review imaging reports or laboratory results to check for unplanned attendances which may have occurred
o Each team should regularly check that all patients are captured during the audit period to ensure consecutive patients are included
o Regular checks should be performed to ensure that the data included on the Excel spreadsheet is as complete as possible
· Validation of a unit’s dataset:
o The supervising consultant(s) will be required to submit the total number of upper GI, HPB, colorectal, renal, urological, and vascular operations performed at their Trust between 17th November 2014 and 0759 1st December 2014 as reported by the Trust’s Coding department to national administrative datasets or from any other local system
o Data completeness for all submitted fields should be 95% or greater.
· Data collation:
o Data will be submitted centrally with all patient identifiers removed. Data will be transferred by the secured NHS.net email service (). Patient anonymised data will be then be analysed and reported by the writing committee.
o Outcome data specific to each individual surgeon who participates will not be collected
o Anonymised hospital data will be compared; but individual surgeons, hospitals or NHS Trusts will not be identified and will be keep strictly anonymous
· Authorship:
o Preparation of the manuscript for publication will be by performed by a writing committee.
o Collaborators (maximum 4 per hospital including supervising consultant) contributing to the running of the study and data collection will be eligible to be listed as ‘Pubmed’ citable authors. In return, each collaborating team should participate in the creating of the local system, registering the audit, identifying patients, collecting data and completing 30-day follow-up.
o Units who fail to submit data or if a Unit’s data is removed will be excluded from the authorship list
o If substantially incomplete data is submitted the writing committee may decide to exclude that unit from further analysis
9.0 DEFINITIONS
The following definitions will be used for this study:
Preoperative
1. Age in years
2. Gender
3. Body Mass Index (BMI) is defined as s defined as the individual's body mass (in kg) divided by the square of their height (in metres) and will be sub-classified as:
· Underweight <17.9
· Normal 18.0 – 24.9
· Overweight 25.0 – 29.9
· Moderately Obesity 30.0 – 34.9
· Severe Obesity 35.0 – 39.9
· Very severe Obesity >40.0
4. American Society of Anesthesiologists (ASA) physical status classification system is a system for assessing the fitness of patients before surgery. These are:
1. A normal healthy patient
2. A patient with mild systemic disease
3. A patient with severe systemic disease
4. A patient with severe systemic disease that is a constant threat to life
5. A moribund patient who is not expected to survive without the operation
5. Diagnosis of Chronic Obstructive Pulmonary (or Airway) Disease (Yes / No, as from past medical notes)
6. Current smoker or stopped in the last 2 months (Yes / No, as from preadmission notes)
7. Previous cerebral vascular accident (Yes / No, as from past medical notes)
8. Blood urea (in mg/dL at preassessment clinic)
9. Long-term (>3 months in the last 12 months) or current steroid use (Yes / No, as from preadmission notes)