6.8Maintaining patient homeostasis

Oxygenation
Bibliographic detailsStudy type and evidence levelNo. of patientsPatient characteristicsIntervention and comparisonOutcome measures, follow-up, effect sizeComments
Greif (2000) 116

Austria and Germany
RCT

EL = 1+
Total no. of patients
n = 500

Intervention group
n = 250
Control group
n = 250
Patients from 18 to 80 years old undergoing open elective colorectal resection (for cancer or IBD)

Exclusion criteria
Minor colon surgery; recent fever or infection; serious malnutrition; bowel obstruction
Intervention group
80% FiO2 during surgery and for the following 2 hours after the intervention

Control group
30% FiO2 during surgery and during the following 2 hours after the operation

Comparison
Peri-operative 80% FiO2 vs
Peri-operative 30% FiO2
Follow-up
15 days

Outcome
Surgical site infection

Effect size
SSI rate
Intervention group
13/250 (5.2%)
Control group
28/250 (11.2%)
Funding
Source of Funding: National Institutes of Health and Grants from several foundations
Mayzler (2005)119

Israel
RCT

EL = 1+
Total no. of patients
n = 38

Intervention group
n = 19
Control group
n = 19
Patients undergoing elective colorectal cancer surgery

Exclusion criteria
ASA score 3 or 4; BMI = 35; diabetes mellitus; COPD; serious malnutrition; preoperative immunosuppression therapy.
Intervention group
80% FiO2 during surgery and for the following 2 hours after the intervention

Control group
30% FiO2 during surgery and during the following 2 hours after the operation

Comparison
Peri-operative 80% FiO2 vs
Peri-operative 30% FiO2
Follow-up
one Month

Outcome
Surgical Site Infection

Effect size
SSI rate
Intervention group
2/19 (12.5%)
Control group
3/19 (17.6%)
Funding
not mentioned
Pryor (2004)118

USA
RCT

EL = 1+
Total no. of patients
n = 165

Intervention group
n = 85
Control group
n = 80
Patients undergoing major intra- abdominal surgery older than 18 years.

Exclusion criteria Laparoscopic procedures; respiratory status requiring FiO2>35%; severe COPD; haemodynamically unstable before surgery; treatment with Bleomycin; ASA score 5 or 5E.
Intervention group
80% FiO2 during surgery and for the following 2 hours after the intervention

Control group
35% FiO2 during surgery and during the following 2 hours after the operation

Comparison
Peri-operative 80% FiO2 vs
Peri-operative 35% FiO2
Follow-up
14 days

Outcome
Surgical Site Infection

Effect size
SSI rate
Intervention group
20/80 (25%)
Control group
9/80 (11.3%)
Funding
Cornell University

165 randomised; 80 in the 35% FiO2 group and 85 in the 80% FiO2; 5 patients left the 80% FiO2 group after randomisation but before the randomisation was revealed: they were not included in the Analysis.

O2 could be increased as required during procedure to maintain SaO2>94% by pulse oximetry.
Belda (2005)117

Spain
RCT

EL = 1+
Total no. of patients
n = 300

Intervention group
n = 150
Control group
n = 150
Patients aged 18–80 years who underwent elective colorectal surgery

Exclusion criteria
Minor colon surgery or laparoscopic surgery; expected time of surgery < 1 hour; fever or existing infection; diabetes mellitus; HIV infection; weight loss >20% in previous 3 months; serum albumin < 30 g/L; leucocyte count < 2500 cells/ml
Intervention group
80% inspired oxygen intra-operatively and for 6 hours after surgery

Control group
30% inspired oxygen intra-operatively and for 6 hours after surgery

Comparison
Peri-operative 80% FiO2 vs
Peri-operative 30% FiO2
Follow-up
14 days

Outcome
Surgical Site Infection

Effect size
SSI rate
Intervention group
14.9% (22/148)
Control group
24.4% (35/143)

RR 0.61 (95% CI 0.38 to 0.98)
After adjusting for confounding variables, RR 0.46 (95% CI 0.22 to 0.95)

Number of patients with ASEPSIS score >20 on any day
Intervention group
16.9% (25/148) Control group
25.9% (37/143)
Funding
Institutional support, Air-LiquideMedicinal and Air-Liquide Sante’

After randomisation nine patients were excluded; they were not included in the Analysis.
Whitney (2001)120

USA
RCT

EL = 1−
Total no. of patients
n = 24

Intervention group
n = 13
Control group
n = 11
Participants undergoing cervical fusion and/or excision of cervical intervertebral disk, between 18 and 80 yo, able to speak and write in English and to give informed consent, discharged from PACU without supplemental O2.Intervention group
Supplemental FiO2 at 28% during the following 36 hours after discharge from the PACU

Control group
Standard treatment (room air) after discharged from the PACU

Comparison
Postoperative supplemental FiO2
vs.
Standard care without supplemental FiO2
Follow-up
one Month

Outcome
Wound healing/Surgical Site Infection (ASEPSIS score > 20)

Effect size
SSI rate
All patients had ASEPSIS score in range of satisfactory healing (0–10); no significant differences between mean scores of groups (data not shown).
Funding
Not mentioned

Unclear reporting
Perfusion
Bibliographic detailsStudy type and evidence levelNo. of patientsPatient characteristicsIntervention and comparisonOutcome measures, follow-up and effect sizeComments
Kabon 2005121

Country USA
RCT

EL = 1+
Total no. of patients
n = 256

Intervention group
n = 131

Control group
n = 125
Patients from 18 to 80 years old undergoing open elective colon resection

Exclusion criteria
History of infection or fever, malignant hyperthermia, congestive heart failure, diuretic therapy, renal failure, pulmonary oedema.
Intervention group
Large fluid management:
-

10 ml/kg fluid bolus pre-anaesthesia

-

lactated Ringer 16–18 ml/kg/h during surgery and for the 1st hour after

Control group
Small fluid management:

lactated Ringer 8–10 ml/kg/h during surgery and for the 1st hour after

Comparison
Supplemental fluid therapy
vs
Standard care
Follow-up
15 days

Outcomes
-

Surgical site infection (CDC definition criteria)

-

Wound healing (ASEPSIS score)

-

ICU admission

-

Hospitalisation

SSI rate
Intervention group: 8.5%
Control group: 11.3%
P= 0.462

ASEPSIS score
Intervention group: 16 ± 7
Control group: 14 ± 8
P = 0.698

ICU admission
Intervention group: 6.2%
Control group: 2.4%
P = 0.140

Length Hospitalisation (days)
Intervention group: 7 ± 5.4
Control group: 7.3 ± 4
P = 0.7
Funding
Supported by several Austrian and US foundations and by US national grants
Perioperative blood glucose control
Bibliographic detailsStudy type and evidence levelNo. of participantsParticipants characteristicsIntervention and comparisonOutcome measures, follow-up and effect sizeComments
Bilotta 2007123
Italy
RCT

EL = 1+
Total no. of patients

n = 78
Randomised in two arms:

Intervention group n = 40
Control group n = 38
Patients with acute SAH admitted to a postoperative neurosurgical ICU after surgical clipping of intracranial aneurysm

Exclusion criteria:
No written inform consent; Endotracheal intubation; Rankin disability score > 1
Intervention group
Intensive insulin therapy (adjusted to maintain glycaemia within 80 and 120 mg/dl)

Control group
Standard insulin therapy (adjusted to maintain glycaemia within 80 and 220 mg/dl)

Comparison
Intensive blood glucose control
vs
Standard blood glucose control
Follow-up
on the patient’s discharge from the ICU or on postoperative day 14 (mean duration)
Intensive insulin group: 9.2 ± 1.9 days
Standard insulin group: 11.4 ± 1.7 days

Outcome
Overall infectionpneumonia, sepsis, urinary and wound infection (NNIS definition criteria)
* Wound infection was reported as a percentage of the overall infection rate

Effect size
Total infection rate
Intervention group 11/40 (27%)
Control group 16/38 (42%)
P < 0.001

Wound infection (% of total infection rate)
Intervention group 11%
Control group 13%
Funding
Departmental research funds
Comments
other outcomes reported in the study: infection rate, mortality, vasospasm and neurological status

Two patients in the intensive insulin group and four in the conventional insulin group were not given insulin therapy because blood glucose never exceeded the defined thresholds.

The Surgical site infection outcome was unclearly reported
Grey 2004122
USA
RCT

EL = 1−
Total no. of participants

n = 61
Randomised in two arms:

Intervention group
n = 34
Control group
n = 27
Adult patients of a general surgical ICU and requiring treatment for hyperglycaemia

Exclusion criteria:
No written informed consent; Patients expected to have a brief stay in the unit or not expected to survive beyond 48 hours; patients with active infections, disseminated cancer or receiving chemotherapy, irradiation or corticosteroids
Intervention group
Strict glucose control
(serum glucose values between 80–120 mg/dl)

Control group
Standard control group
(serum glucose values between 180–220 mg/dl)

Comparison
Strict blood glucose control vs
Standard glucose control
Follow-up
n.s. (duration of the surgical ICU stay)

Outcome
SSI (CDC definition criteria)

Effect size
SSI
Intervention group: 30% *estimated from histogram

Control group: 7%
*estimated from histogram
Funding
Ns

Comments
Other outcomes reported in the study: serum glucose values and nosocomial infections (among which SSI)

Exact SSI rates were not reported

From: Evidence tables

Cover of Surgical Site Infection
Surgical Site Infection: Prevention and Treatment of Surgical Site Infection.
NICE Clinical Guidelines, No. 74.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2008 Oct.
Copyright © 2008, National Collaborating Centre for Women’s and Children’s Health.

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