Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

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Table 23 Patient criteria of included studies focusing on the use of HBOT in necrotising soft tissue infections. First Author and Year of Publication Brown 1994 52 Patient Criteria Patients diagnosed with necrotising faciitis, crepitant anaerobic cellulitis, gangrene, Fournier’s gangrene, or nonclostridial/clostridial myonecrosis. Exclusions: complications of radiotherapy, primary peripheral vascular disease with dry gangrene, gangrene as a single diagnosis, joint reconstruction complications, or an infection only involving an extremity. Riseman 1990 53 Patients diagnosed with necrotising fasciitis, gas gangrene, or Fournier’s gangrene. Interventions examined Exposure to hyperbaric oxygen was different in both studies (Table 24). In the study by Brown et al, 52 pressures were higher and the frequency of therapy was unstated. Riseman et al53 made use of a treatment regimen that called for frequent exposure to HBOT in the first 24 hours of therapy. Comparison therapies were standard. Table 24 Therapeutic protocols used in intervention and comparison groups in included studies focusing on the use of HBOT in necrotising soft tissue infections.* First Author and Year of Publication Brown 1994 52 Riseman 1990 53 Intervention Group Comparison Group n=30 Comparison therapy plus treatment in an unstated chamber HBO device at 2.5 to 3.0 ATA for 90 minutes.† n=17 Comparison therapy plus treatment in a monoplace chamber HBO device. At 2.5 ATA for 90 minutes every 8 hours for the first 24 hours, the twice a day, for a total of 10 treatments. * Abbreviations: ATA = atmosphere absolute, n = sample size. † Duration of therapy not described. n=24 Debridement, antibiotics, laparotomy. n=12 Intravenous fluids, debridement, broad spectrum antibiotics (aminoglycoside, clindamycin, and penicillin G or cephalosporin). Assessment of heterogeneity Differences in patient criteria and study designs made it difficult to compare clinical and epidemiological outcomes in the two studies. For this reason, the review undertook no statistical analysis of heterogeneity and made no attempt to arrive at a statistically pooled effect estimate through meta-analysis. Review of published clinical experience Both studies looked at the proportion of patients who survived following the diagnosis of necrotising soft tissue infections (Table 25). Both studies showed that HBOT was associated with survival, but only Riseman et al53 reached commonly accepted levels of statistical significance. 34 Hyperbaric oxygen therapy
Summary Table 25 Survival in patients with necrotising soft tissue infections following exposure to HBOT or comparison therapy.* First Author and Year of Publication Intervention Survival Comparison Difference p Brown 1994 52 70.0 (53.6, 86.4) 58.3 (38.6, 78.1) 11.7 (-14.0, 37.3) 0.3724 Riseman 1990 53 76.5 (56.3, 96.6) 33.3 (6.6, 76.6) 43.1 (9.7, 76.6) 0.0202 * Results are in percentages. Figures in parentheses are 95% confidence intervals. In addition to overall survival, Brown et al 52 looked at the mean number of operations and debridements in intervention and comparison groups. In both instances, those receiving HBOT underwent more operations (Mean ± SD: 3.2 ± 1.6 versus 1.7 ± 1.5; p = 0.0009) and debridements (Mean ± SD: 2.4 ± 1.5 versus 1.3 ± 1.0; p = 0.0033). The studies identified looked at different populations of patients and their research designs were dissimilar. Overall, there was some indication that HBOT improved survival in patients with necrotising soft tissue infections. However, one study indicated that the number of operations was increased in the intervention group. This evidence is insufficient to allow firm, generalisable, conclusions about the effect of HBOT on necrotising infections in general given the methodological issues described above and the unexplained increase in surgical intervention in the intervention group found in one study. Necrotising fasciitis For this indication three studies were identified from the published literature that met inclusion criteria. A brief description of each study is given in Table 26. Table 26 Descriptive characteristics of included studies focusing on the use of HBOT in necrotising fasciitis.* First Author and Year of Publication Shupak 1995 54 Sawin 1994 55 Barzilai 1985 56 NHMRC Level III-2 III-2 III-2 Study Design Location Comparative study Comparative study Comparative study Israel USA Israel Dates of Enrolment 1984 to 1993 Jan 1982 to Mar 1993 1979 to 1983 Characteristics of Study Population † Hyperbaric oxygen therapy 35 Size 37 7 11 Age (years) Mean (SD) I=52.9 (15) C=57.4 (16) 9 days (3- 15) § I=48.33 (12.5) C=55.88 (9.2) Sex Ratio (M:F) I=14:11 C=9:3 ? I=3:0 C=6:2 * Abbreviations: C = comparison group, F = female, I = intervention group, M = male, RCT = randomised controlled trial, SD = standard deviation. † Information is given for intervention and comparison groups, if available. Otherwise, total study population values are stated. ‡ Unstated, unclear, or unknown. § Figures in parentheses are ranges. The studies were published over a period of 10 years. Two were performed in Israel. 54,56 The sample sizes varied from seven to 37. None of the studies were RCTs. Most study participants were males.
Page 1 and 2: Hyperbaric Oxygen Therapy November
Page 3 and 4: Contents Executive summary.........
Page 5 and 6: Tables Table 1 Measures of disease
Page 7 and 8: Table 45 Functional neurologic scor
Page 9 and 10: Figures Figure 1. Outline of search
Page 11 and 12: Effectiveness Published guidelines
Page 13 and 14: evidence that exposure to HBO may b
Page 15 and 16: No available evidence No evidence w
Page 17 and 18: Introduction The Medicare Services
Page 19 and 20: Multiplace chambers can accommodate
Page 21 and 22: Marketing status of the device The
Page 23 and 24: Table 3 1998 - 1999 self-reported d
Page 25 and 26: Table 6 retrieval. Indication-speci
Page 27 and 28: Phase of Search Initial Search Ful
Page 29 and 30: Conduct of meta-analysis When the d
Page 31 and 32: early as 1995. The guidelines - kno
Page 33 and 34: Table 10 Minimum staff qualificatio
Page 35 and 36: Is it effective? The review assesse
Page 37 and 38: Table 14 Patient criteria of includ
Page 39 and 40: offered ample details. The remainin
Page 41 and 42: characteristics compared to the tre
Page 43 and 44: Assessment of heterogeneity All the
Page 45 and 46: Odds ratio 10 1 0.1 0.01 A sensitiv
Page 47 and 48: Wound healing Two of the five ident
Page 49: Studies of necrotising soft tissue
Page 53 and 54: Table 29 Therapeutic protocols used
Page 55 and 56: Osteomyelitis The study by Esterhai
Page 57 and 58: Summary The HBO group showed a stat
Page 59 and 60: Summary These results are difficult
Page 61 and 62: outcomes or that decreased the risk
Page 63 and 64: Anderson et al 80 recruited non-pre
Page 65 and 66: Summary The collected evidence exam
Page 67 and 68: Table 46 Major outcomes following t
Page 73 and 74: Thirty-seven subjects (comparison g
Page 75 and 76: whose hearing loss was not secondar
Page 77 and 78: tinnitus (6 versus 3 subjects). Non
Page 79 and 80: assume that all participants knew o
Page 83 and 84: Table 65 Descriptive characteristic
Page 87 and 88: These contrasted with the conclusio
Page 91 and 92: Summary There are conflicting resul
Page 93 and 94: Summary separate and previously-stu
Page 95 and 96: need to insulate patients from outs
Page 97 and 98: Reactive effects A reactive effect
Page 99 and 100: Cost of major amputation The hospit
Page 101 and 102:
Sensitivity analysis Table 79 shows
Page 103 and 104:
Table 80 Estimation of incremental
Page 105 and 106:
Sensitivity analysis Table 83 shows
Page 107 and 108:
Conclusions Safety Potential risks
Page 109 and 110:
Recommendations MSAC recommended th
Page 111 and 112:
Appendix B Supporting committee Sup
Page 113 and 114:
Appendix C Studies included in this
Page 115 and 116:
Necrotising soft tissue infections:
Page 117 and 118:
Soft tissue injuries: crush injurie
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Cancer: cervix First Author and Yea
Page 121 and 122:
Appendix D Studies excluded in this
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2. Shandling AH, Ellestad MH, Hart
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5. Woo TCS, Joseph D, Oxer H. Hyper
Page 127 and 128:
22. Kunkler PB, Boulis-Wassif S, Sh
Page 129 and 130:
45. Wiernik G, Perrins D. The radio
Page 131 and 132:
Appendix E Calculation of monoplace
Page 133 and 134:
Hence, the total operating costs of
Page 135 and 136:
Appendix G Reviews received from ot
Page 137 and 138:
Sechrist Industries -- Hyperbaric O
Page 139 and 140:
References 1. Hampson N. Hyperbaric
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31. L'Abbe K, Detsky A, O'Rourke K.
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61. Perrins DJ. Influence of hyperb
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89. DiSabato F, Giacovazzo M, Crist
Page 147:
117.Plenk HP. Hyperbaric radiation
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