Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

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The study by Sawin et al 55 was distinctly different from the others since the subjects were neonates. In the other two studies the mean age of participants was above 45 years. Study quality Most of the studies failed to provide any information about masking procedures, except Sawin et al55 in which no masking was done. All studies reported complete follow-up of subjects (Table 27). Table 27 Methodological quality of included studies focusing on the use of HBOT in necrotising fasciitis. First Author and Year of Publication Patient criteria Study Design Randomisation Masking Losses to Follow-up Shupak 1995 54 Comparative study None Unclear No losses Sawin 1994 55 Comparative study None None No losses Barzilai 1985 56 Comparative study None Unclear No losses Inclusion criteria were defined on the basis of a clinical diagnosis of necrotising fasciitis based on signs and symptoms (Table 28). No attempts at standardisation were made. Table 28 Patient criteria of included studies focusing on the use of HBOT in necrotising fasciitis. First Author and Year of Publication Patient Criteria Shupak 1995 54 Patients diagnosed with necrotising fasciitis. Sawin 1994 55 Neonates diagnosed with necrotising fasciitis of the abdominal wall. Barzilai 1985 56 Patients diagnosed with necrotising fasciitis. Interventions examined All comparison therapies consisted of surgical debridement, broad spectrum antibiotics, and dressings (Table 29). Surgical debridement was described as “aggressive,” and antibiotic regimens were modified following the results of microbial sensitivity. In two of the studies, 55,56 HBOT was not described in adequate detail. No description was given of the pressures to which subjects were exposed or the frequency, duration, and total period of therapy. 36 Hyperbaric oxygen therapy
Table 29 Therapeutic protocols used in intervention and comparison groups in 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 Intervention Group Comparison Group n=25 Comparison therapy plus treatment in a monoplace HBO chamber with 100% oxygen at 2.5 ATA for 90 minutes twice a day, then once daily until toxic signs resolve. n=4 Comparison therapy plus HBOT.† n=3 Comparison therapy plus HBOT.† * Abbreviations: ATA = atmosphere absolute, n = sample size. † Therapy not described. n=12 Debridement, broad spectrum antibiotics, dressings. n=3 Intravenous antibiotics, surgical debridement in some patients, dressings. n=8 Intravenous fluids and antibiotics (gentamicin, clindamycin, penicillin) modified following sensitivity results, debridement, dressing with nitrofurazone and povidone-iodine. Assessment of heterogeneity The Sawin et al55 study was clearly not comparable with the other two studies on clinical and epidemiological grounds. Even when considering the adult studies alone, 54,56 biasprone research designs, small sample sizes, and insufficient information about the interventions studied illustrated clinical and epidemiological heterogeneity between the studies. For this reason, the review undertook no statistical analysis of heterogeneity for this indication and made no attempt to arrive at a statistically pooled effect estimate through meta-analysis. Review of published clinical experience Sawin et al55 studied two groups of neonates diagnosed with necrotising fasciitis of the abdomen. Hyperbaric oxygen was used as an adjunct to care after 2 deaths from the condition prompted increased vigilance. Two of four neonates receiving HBOT survived, compared to none of three receiving conventional care. Two studies examined the experience of adults diagnosed with necrotising fasciitis. In the study by Shupak et al, 54 survival was seen in 16 of 25 (64%; 95% CI = 43, 82%) patients receiving HBOT compared to 9 of 12 (75%; 95% CI = 43, 95%) receiving the comparison procedure. The study by Barzilai et al 56 was performed ten years earlier and examined about one-third the number of patients. Similar results for survival were seen: two of three patients (66%; 95% CI = 9, 99%) receiving HBOT versus five of eight (62%; 95% CI = 24, 91%) receiving the comparison therapy. Shupak et al 54 also examined the number of times the two groups underwent debridement and found that the comparison group underwent a statistically significantly lower mean number of debridements compared to those receiving HBOT (Mean ± SD: 1.5 ± 0.8 versus 3.3 ± 2.0; p = 0.0004). No statistically significant differences in length of hospital stay were seen (Mean ± SD: 15.9 ± 6.4 days in the HBOT group versus 20 ± 13.8 days in the comparison group; p = 0.3657). Hyperbaric oxygen therapy 37
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 and 50: Studies of necrotising soft tissue
Page 51: Summary Table 25 Survival in patien
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 69 and 70: Table 50 Therapeutic protocols used
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
Page 119 and 120:
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
Page 141 and 142:
31. L'Abbe K, Detsky A, O'Rourke K.
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61. Perrins DJ. Influence of hyperb
Page 145 and 146:
89. DiSabato F, Giacovazzo M, Crist
Page 147:
117.Plenk HP. Hyperbaric radiation
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