|Year : 2015 | Volume
| Issue : 1 | Page : 76-82
Role of perioperative oxygen supplementation in relation to surgical site infection in urological surgery under neuraxial anesthesia
Md R Karim Habib1, Md Yunus1, L Sailo Stephen2, Bhattacharyya Prithwis1, K Mitra Jayanta1, M Lyngdoh Nari1
1 Department of Anaesthesiology and Critical Care, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Meghalaya, India
2 Department of Urology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Meghalaya, India
|Date of Submission||10-Aug-2014|
|Date of Acceptance||01-Dec-2014|
|Date of Web Publication||25-Mar-2015|
B10-C, Faculty Quarter, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Meghalaya 793018
Source of Support: None, Conflict of Interest: None
Hyperoxia exerts variable effects on multiple cellular and immunologic parameters and offers potential benefits from use of supplemental oxygen. Supplementation with high concentration of O 2 has been shown to reduce colorectal anastomotic leakage by 50% and subsequently its use has been recommended to reduce surgical site infection (SSI) by surgical associations of America and Canada. We designed this randomized controlled trial to determine the impact of O 2 supplementation on the incidence of SSI in urological surgeries performed under neuraxial anaesthesia.
The aim of the study was to evaluate whether use of supplemental high-concentration perioperative oxygen decreases the risk of post-uro-SSI as it did after colorectal surgery in previous studies.
The study was conducted in the Department of Anaesthesiology and Critical Care in collaboration with the Department of Urology at our institute after obtaining clearance from the Institute of Ethical Committee and written informed consent from patients enrolled in this study.
Patients and methods
Eighty ASA grade I and II patients, aged between 15 and 60 years, undergoing selected urological surgeries were randomly assigned to two equal groups after they had fulfilled inclusion and exclusion criteria. One group received 8-10 l O 2 /min through a non-rebreathing face mask during the intraoperative period, which was continued in the postoperative period for about 6 h, whereas the other group continued breathing room air. Data were collected by physicians from the Department of Urology who were blinded to the intervention and were analysed using INSTAT software with appropriate statistical tools.
Demographic, physical, preoperative, intraoperative and postoperative haemodynamic parameters in both groups were comparable (P > 0.05). Although our study showed a tendency towards reduction in SSI (17.5 vs. 12.5%), compared with the control group, the difference was not statistically significant (P > 0.05).
Perioperative high-concentration oxygen supplementation does not reduce SSI in clean contaminated types of wounds in urological surgeries.
Keywords: neuraxial anaesthesia, oxygen therapy, surgical site infection, urosurgery
|How to cite this article:|
Habib MK, Md Yunus, Stephen L S, Prithwis B, Jayanta K M, Nari M L. Role of perioperative oxygen supplementation in relation to surgical site infection in urological surgery under neuraxial anesthesia. Ain-Shams J Anaesthesiol 2015;8:76-82
|How to cite this URL:|
Habib MK, Md Yunus, Stephen L S, Prithwis B, Jayanta K M, Nari M L. Role of perioperative oxygen supplementation in relation to surgical site infection in urological surgery under neuraxial anesthesia. Ain-Shams J Anaesthesiol [serial online] 2015 [cited 2021 May 6];8:76-82. Available from: http://www.asja.eg.net/text.asp?2015/8/1/76/153945
| Introduction|| |
Surgical site infection (SSI) is an important type of healthcare-associated infection and its prevention is of utmost importance. A recent prevalence study found that SSIs are the most common healthcare-associated infections  . It is one of the most stressful conditions for the patient and medical team with significant impact on both individuals and the society. It increases the length of hospital stay as well as cost of care for the patient, through requirement for healthcare providers and patient attendants, and affects the quality of life, increasing morbidity and mortality , .
The process of wound healing consists of four highly integrated and overlapping phases: haemostasis, inflammation, proliferation and tissue remodelling or resolution  . Wound hypoxia impairs each of the components of healing  . Systemic factors like age, medical comorbidities, nutrition and sympathetic nervous system activation and local environmental factors including bacterial load, degree of inflammation, moisture content, oxygen tension and vascular perfusion also have a profound effect on healing  . Although all of these factors are important, perhaps the most critical element is oxygen supply to the wound. Tissue oxygen tension level is one of the best established predictors of SSIs , . Experimental models as well as human clinical experience ,, have led to the conclusion that wound healing is delayed in hypoxic wounds.
Neutrophils are the primary cells responsible for nonspecific immunity and their function depends on a high partial pressure of oxygen , . Phagocytosis of the pathogen activates the NADPH-linked oxygenase present in the phagocytic membrane, which uses oxygen as the substrate to catalyse the formation of superoxide. Superoxide is bactericidal. Oxidative burst function of neutrophils is one of the primary defences against SSI  and it depends on the PO 2 concentration over the entire physiological range of tissue values  .
Wounds are most susceptible to infection in the first few hours after surgery. Antibiotics lose their effectiveness after the initial hours, whereas oxygen-mediated natural wound immunity lasts longer  . Interventions to improve tissue oxygenation during or immediately after surgery are thus most likely to reduce the morbidity and mortality associated with SSI , . Hyperoxia also exerts significant effects on multiple cellular and immunologic parameters, providing a potential mechanism for benefits from the use of supplemental oxygen  . We have conducted this prospective double-blind controlled study to reveal potential benefit of supplemental O 2 therapy in preventing SSI in patients undergoing urosurgical procedures under neuraxial block.
| Patients and methods|| |
After obtaining clearance from the Institute of Ethical Committee and after obtaining informed consent from patients, the study was conducted in the Department of Anaesthesiology, Critical Care and Pain Medicine with cooperation from the Department of Urology of the North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, India.
Eighty patients of ASA grade I or II, aged between 15 and 60 years from either sex, undergoing urosurgical surgeries were enrolled in this study. Patients having uncontrolled diabetes mellitus, immunocompromised disease, sepsis or infective foci elsewhere in the body, and end organ damage and SpO 2 less than 92% at room air, were excluded from the study. Patients with treated urinary tract infection and mild-degree renal failure due to the disease for which surgery was being performed were included in the study population. Uniform random numbers from 1 to 100 were generated using Microsoft Excel 2007 (Microsoft Corporation, Redmond, Washington, USA) using the formula RANDBETWEEN (1-100), and the second time from 1 to 22 (1-22 total). Alternate random numbers were divided into two groups (A and B) and sealed in 122 envelopes. Then, 122 consecutive eligible patients were asked to pick one of the envelopes, which was opened in the operation theatre. Patients who were assigned to group A were not given supplemental oxygen and patients in group B were given supplemental oxygen.
The entire study population received a single dose  of ceftriaxone within 1 h of starting of surgery as prophylaxis to prevent SSI according to the guidelines issued by the Centre for Disease Control for prevention. The antibiotic given was different for those patients whose preoperative urine culture showed organisms that were resistant to ceftriaxone. Such patients received an appropriate sensitive antibiotic at least 3 days before surgery. Patients in group A breathed room air throughout the intraoperative and postoperative period. Patients in group B were given supplemental oxygen through a Venticare adult non-rebreathing mask with a head strap, tube and nose clip from Flexicare Medical Limited, USA at 8-10 l/min, which was started immediately after neuraxial anesthesia and was continued up to 6 h postoperatively in the Postanaesthetic Care Unit/High Dependency Unit. After 6 h, oxygen was given only if the patient was unable to maintain saturation of 92%, in amounts needed to maintain 92% or more. Postoperative care was determined by the attending intensivist/physician/surgeon for both groups and normothermia and normoglycaemia were maintained. Perioperative fluid therapy was guided by British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients Recommendations  and by the protocol of Holliday and Seger  .
Data were collected from every patient as follows:
In the preoperative period, the name, age, sex, central record number, nutritional status, pulse, blood pressure, temperature, height, weight, BMI, Hb, total leucocytic count, differential count and random blood sugar levels of the patients were recorded. Both spinal anaesthesia and combined spinal epidural technique were used for the surgery. The local anaesthetic used was 0.5% bupivacaine (heavy) for spinal anesthesia with or without 20-25 μg fentanyl. Ropivacaine (0.2%) was given for postoperative analgesia through the epidural route.
- From preoperative clinical examination and laboratory records.
- During the intraoperative period.
- From postoperative evaluations including laboratory tests.
- From follow-up in the outpatient department for 30 days if patients were discharged before 30 days.
Blood samples were collected through radial artery puncture using a well-flushed heparinized 2 ml single-use syringe after 45 min of neuraxial anaesthesia and analysed in a Roche Cobas b 221 system (Hoffmann-La Roche Ltd., Basel, Switzerland) and ESCHWEILER combiline CL 1234568-12-HB (Eschweiler Gmbh Co., Kiel, Germany) blood gas analyser machines. Intraoperative heart rate, blood pressure and temperature were also recorded at that time. Patients were evaluated by physicians from the Department of Urology who were unaware about the study design. Occurrence of SSI as per the definition of the National Institute of Clinical Excellence (NICE) SSI definition  was recorded daily. The highest temperature of the day and average heart rate and blood pressure of the day were recorded in the vital record chart. Total leucocytic count was measured only in those patients whose temperature was above 102°F from the third postoperative day (POD) onwards and wound swab was collected for gram staining and culture sensitivity if there was purulent or mucopurulent discharge from the wound, or if the evaluating physician suspected clinical infection and opened the wound.
Most of the patients were discharged from the seventh POD onwards. Patients were followed up in the urology outpatient department for 30 days.
Statistical data analysis
Sample size calculation
Sample size was calculated online from http://www.sealedenvelope.com using a power (sample size) calculator for binary outcome noninferiority trial formula. The prevalent success rate (no SSI) was determined from a sample from the urology ward in the previous month before starting the study, which showed that 75% of patients were free of infections as per the definition being used in our study. We expected 50% reduction in SSI (success rate or no SSI in 87.5%) with oxygen supplementation, as shown in a previous study. The noninferiority limit was taken as 5% based on the approximate cost of treatment of one SSI and cost of treatment in the experimental group for the expected number of patients needed to be treated to obtain 50% reduction in the experimental group. The sample size was calculated to be 60 in each group (120 totals) to have 80% power to achieve the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval).
Forms of data presentation
Patient demographic data, baseline haemodynamics, ASA physical status, haemodynamics, temperature, blood sugar, duration of surgery, temperature and lactate levels are presented as parametric data. SSI data are presented as binary data (present/absent).
The collected data were analysed statistically using the unpaired t-test for parametric data and Fisher's exact test for nonparametric data using INSTAT software (GraphPad Software, Inc., La Jolla, California, USA). The χ2 -test of independence was used to analyse data in the contingency table. Two-tailed P value was calculated for significance and a value less than 0.05 was taken as significant. The person performing the analysis was blinded to the intervention.
| Observation and results|| |
In this single blind, prospective, randomized control trial, difference between the groups was not significant with respect to age group distribution, sex, height, comorbid conditions and preoperative parameters like heart rate, blood pressure, temperature, random blood sugar, haemoglobin, total leucocyte count and differential leucocyte count (P > 0.05) ([Table 1]). Therefore, both groups were comparable. The mean ASA physical status grade in group A was 1.12 with an SD of 0.33, whereas the mean ASA physical status grade in group B was 1.20 with an SD of 0.40 ([Table 1]).
The ranges of BMI in both groups were between 17.5 and 25.5 kg/m 2 and clinically patients of both groups were well nourished. The mean weight (52.00 ± 1.22 kg) and BMI (21.25 ± 0.33 kg/m 2 ) of group A was slightly higher than those of group B (mean weight 48.12 ± 1.25 kg and BMI 20.18 ± 0.27 kg/m 2 ) and the difference was statistically significant (P<0.05).
Both groups were comparable with respect to duration and type of surgery performed ([Table 2]). The mean duration of surgery in group A was 97.8 min with an SD of 55.8 min ranging between 35 and 225 min, whereas the mean duration of surgery in group B was 99.8 min with an SD of 49.3 min ranging between 40 and 225 min; the difference was not statistically significant (P = 0.8657).
High-concentration oxygen supplementation by means of a non-rebreathing face mask in group B was effective as shown by arterial PO 2 mean value of 311.25 ± 7.59 mmHg as compared with group A in which the mean value was 76.43 ± 0.95 mmHg, the difference being highly significant (P<0.0001).
Intraoperative haemodynamics and other parameters of both groups were comparable ([Table 1]).
Postoperative haemodynamics up to the seventh POD were also comparable between groups ([Table 2]). No vasopressor was needed in either group in the postoperative period. Although the mean temperature of group B was higher by 0.37°F compared with group A on the second POD, it was nearly the same in both groups from the third POD onwards, and the difference was not statistically significant (P > 0.05).
The incidence of SSIs was higher in group A (the nonoxygen group) compared with group B (the supplemental oxygen group). A total of seven out of 40 patients of group A (17.5%) developed SSIs as compared with five out of 40 patients of group B (12.5%) within 30 PODs. Although group A had more number of SSIs as compared with group B the difference was not statistically significant (P = 0.7555) ([Table 2]).
Patient compliance as a result of detailed explanations and reassurance was generally good, but 16 out of 40 (40%) patients complained of a feeling of suffocation with the mask. All patients (40 out of 40) of group B (high concentration oxygen supplementation group) complained of dryness of the mouth, nostrils and nasopharynx.
| Discussion|| |
There is little doubt that the presence of low subcutaneous concentrations of O 2 at wound sites impairs the antibacterial functions of neutrophils and promotes the development of wound infections. Experimental models as well as human clinical experience ,, have also led to the conclusion that wound healing is delayed in hypoxic wounds. Further, oxygen partial pressures and wound tissue oxygen concentrations have been shown to correlate with oxidative killing and thus help to predict SSI rates  .
The study by Greif et al.  raised the issue of whether the delivery of high FIO 2 during the perioperative period could be routinely used to reduce the incidence of SSIs. Belda et al.  and Myles et al.  replicated these findings. Subsequently, the Canadian Association of General Surgeons and American College of Surgeons recommended 80% inspired oxygen to be used for patients undergoing colorectal surgery to prevent SSI  . Greif et al.  randomly assigned 500 patients undergoing colorectal resection to receive 30 or 80% inspired oxygen during the operation and for 2 h afterwards. Among the 250 patients who received 80% oxygen, 13 (5.2%; 95% confidence interval 2.4-8.0%) had surgical wound infections, as compared with 28 of the 250 patients given 30% oxygen (11.2%) (P = 0.01), which was significant. The main difference in our study and the above study was that the latter was colorectal surgery resulting in contaminated  type of wounds - wounds with gross spillage from the gastrointestinal tract and/or with acute, nonpurulent inflammation - or dirty  type of wounds - wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera, whereas our surgery resulted in clean contaminated  type of wounds - wounds in which the genital and urinary tracts were accessed under controlled conditions and without unusual contamination. High-concentration oxygen supplementation was provided through an endotracheal tube under general anaesthesia in the latter study, whereas we administered oxygen through a non-rebreathing facemask. However, arterial oxygenation did not differ much in either study (348 vs. 311 mmHg). Moreover, our control group received 21% oxygen in contrast to 30% and the study group received postoperative supplementation for 6 h in place of 2 h. Although our study group had fewer infections, the decrease was not statistically significant.
In contrast, in another double-blind, randomized controlled trial by Pryor et al.  performed in the general surgical population, 165 patients were assigned to receive either 80% oxygen (FiO 2 of 0.80) or 35% oxygen (FiO 2 of 0.35) during surgery and for the first 2 h after surgery. This study was also performed in patients who received supplemental oxygen through an endotracheal tube under general anaesthesia, similar to that of Greif and colleagues, in contrast to our study. Surprisingly, the incidence of infection was significantly higher in the group receiving FiO 2 of 0.80 than in the group with FiO 2 of 0.35 (25.0 vs. 11.3%; P = 0.02). In this study, multiple types of surgery were performed by 17 different surgeons. Surgical wounds ranged from clean to dirty type  of wounds, which contrasted with our study, in which only clean contaminated  urological cases were investigated under neuraxial anaesthesia.
Unlike Greif et al.  and Pryor et al.  , Gardella et al.  in their double-blind randomized study supplemented high-concentration inspired oxygen through a non-rebreathing mask during the operation and for 2 h afterwards. Gardella et al.  assigned 143 women undergoing caesarean delivery under regional anaesthesia after the onset of labour to receive low-concentration or high-concentration inspired oxygen. Postcaesarean infection occurred in 17 (25%) out of 69 women assigned to high-concentration oxygen compared with 10 (14%) out of 74 women assigned to low-concentration inspired oxygen (relative risk 1.8, P = 0.13). Similar to Pryor et al.  , supplemental high-concentration oxygen was unable to reduce SSI in this study. The median partial pressure of oxygen achieved in the study of patients undergoing colorectal surgery was 348 mmHg compared with 177 mmHg in the treatment arm of the study by Gardella et al.  and 311 mmHg in the current study. This difference in the partial pressure of oxygen can be explained partially by arterial sampling in the colorectal study and our study as opposed to venous sampling in the caesarean section study. Along with incision site infection, Gardella et al.  included endometritis as a postoperative SSI in their study and the study was performed in an otherwise clean wound, in contrast to ours.
The hypothesis that oxidative killing of pathogens is the primary mechanism of defence against surgical pathogens would suggest that the use of high-concentration supplemental oxygen would be beneficial , . Some studies ,, show that increasing inspired O 2 from 30 to 80% results in improved O 2 tension at wound sites, increasing the ability to kill contaminating bacteria and decreasing the incidence and severity of wound infections. However, this beneficial effect was not universal, with some studies failing to reproduce the benefit ,, . Although several explanations were put forward to provide possible reasons for the negative trials, factors such as temperature, volume and pain and vasopressor use, which may indeed affect oxygen tension, were not always adequately controlled in all trials, thereby contributing to variable tissue oxygenation. In our study these were not confounding factors, as adequate measures were taken in our High Dependency Unit by well-trained nurses under supervision of an on-duty doctor in the ICU. No patient needed vasopressor support to maintain haemodynamics.
We conducted this study to evaluate whether high-concentration supplemental oxygen in the perioperative period could decrease the risk of posturological SSI. High-concentration perioperative oxygen therapy is a simple and inexpensive treatment. If it is effective in reducing SSI, it can be an improvement in anaesthetic practice during urological surgeries and would help reduce a major cause of postoperative morbidity. Unfortunately, although our results showed 5% less infection in the oxygen supplement group (17.5 vs. 12.5%, relative risk 1.2 with 95% CI of difference 0.70-2.05) among patients undergoing urological surgeries, it is statistically insignificant (P = 0.7555) and does not suggest to be beneficial in reducing SSI.
Our study also had some limitations without which the results could have been different. The outcome measurement, although consistent with the National Institute for Health and Clinical Excellence SSI definition  , relied on clinical diagnosis of SSI by attending resident doctors as documented in the patient chart and data. It is possible that SSI was overdiagnosed or underdiagnosed, although they were instructed to evaluate as per NICE definition. However, because house staff and study personnel remained blinded to study assignment throughout the duration of the study, this bias seems unlikely to affect the study outcome.
| Conclusion|| |
Supplementation of high-concentration oxygen does not reduce the SSI in the clean contaminated type of wound in urological surgeries. Urological patients belonging to the clean contaminated wound category should not be given supplemental oxygen to reduce SSI until further high-powered study indicates its effectiveness. Further investigation is required to elucidate which type of surgical wounds may benefit from supplemental perioperative oxygen ([Figure 1] [Figure 2] [Figure 3]).
|Figure 3: Hierarchical representation of randomization and analysis of the samples.|
Click here to view
| Acknowledgements|| |
The authors acknowledge the help provided by Senior Resident Doctors of Urology for collecting data.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]
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