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1.
Medicine (Baltimore) ; 100(2): e24183, 2021 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-33466193

RESUMO

ABSTRACT: This study aimed at assessing which one of the 2 therapies is better for treating carbon monoxide (CO) poisoning from the perspective of reducing delayed neuropsychologic sequelae (DNS).We used Taiwan's National Health Insurance Research Database (NHIRD) to conduct a nationwide population-based cohort study to assess which therapy is better for CO poisoning patients. To accurately identify patients with DNS, the definition of DNS is included neurological sequelae, and cognitive and psychological sequele. The independent variable was therapy and the dependent variable was DNS occurred within 1 year after discharge from a medical institution. The control variables were age, gender, the severity of CO poisoning, and comorbidities present before CO poisoning admission.The risk of developing DNS in patients treated with Hyperbaric Oxygen (HBO) was 1.87-fold (P < .001) than normobaric oxygen (NBO) therapy. The severity of CO poisoning and comorbidities were also found to have significant influences on the risk of developing DNS.HBO may be a risk therapy for treating CO poisoning.


Assuntos
Intoxicação por Monóxido de Carbono/complicações , Intoxicação por Monóxido de Carbono/terapia , Progressão da Doença , Oxigenação Hiperbárica/normas , Oxigenoterapia/normas , Adulto , Estudos de Coortes , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigenação Hiperbárica/métodos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos/estatística & dados numéricos , Oxigenoterapia/efeitos adversos , Oxigenoterapia/métodos , Qualidade da Assistência à Saúde/normas
2.
Undersea Hyperb Med ; 47(3): 405-413, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32931666

RESUMO

Objective: Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress. Methods: This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation. Results: We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046). Conclusion: Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Oxigenação Hiperbárica/métodos , Pneumonia Viral/terapia , Pontuação de Propensão , /terapia , Adulto , Idoso , Pressão Atmosférica , Estudos de Casos e Controles , Infecções por Coronavirus/complicações , Infecções por Coronavirus/mortalidade , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/mortalidade , Respiração Artificial/mortalidade , /mortalidade , Fatores de Risco , Segurança , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
3.
Undersea Hyperb Med ; 47(2): 297-298, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32574446

RESUMO

There have been numerous recent inquiries regarding use of hyperbaric oxygen (HBO2) for patients with COVID-19. Questions have been raised pertinent to two possible mechanisms for HBO2 in this clinical context. The UHMS Hyperbaric Oxygen Therapy Committee, UHMS Executive Committee, with collaborative input from multiple senior UHMS members and researchers have drafted this position statement.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Oxigenação Hiperbárica , Pneumonia Viral/terapia , Ensaios Clínicos como Assunto , Infecções por Coronavirus/complicações , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigenação Hiperbárica/métodos , Hipóxia/etiologia , Hipóxia/terapia , Pandemias , Pneumonia/etiologia , Pneumonia/terapia , Pneumonia Viral/complicações , Sociedades Médicas
4.
Diving Hyperb Med ; 50(2): 185-188, 2020 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-32557424

RESUMO

Acute cerebral oxygen toxicity (ACOT) is a known side effect of hyperbaric oxygen treatment (HBOT), which can cause generalised seizures. Fortunately, it has a low incidence and is rarely harmful. Nevertheless, we present a case of a 37 year-old patient with morbid obesity who died unexpectedly after an oxygen toxicity seizure in the hyperbaric chamber. Considering possible causes, physiologic changes in obesity and obesity hypoventilation syndrome may increase the risk of ACOT. Obesity, especially in extreme cases, may hinder emergency procedures, both in- and outside of a hyperbaric chamber. Physicians in the hyperbaric field should be aware of the possibility of a fatal outcome after ACOT through the described mechanisms and take appropriate preventative measures. Basic airway management skills are strongly advised for involved physicians, especially when specialised personnel and equipment are not immediately available.


Assuntos
Morte Súbita , Oxigenação Hiperbárica , Oxigênio , Adulto , Morte Súbita/etiologia , Humanos , Oxigenação Hiperbárica/efeitos adversos , Obesidade Mórbida , Oxigênio/efeitos adversos , Convulsões/induzido quimicamente , Convulsões/terapia
7.
Medicine (Baltimore) ; 99(16): e19857, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32312010

RESUMO

BACKGROUND: Our study aimed to screen and explore the expression of inflammatory factors in keloid patients and to investigate how hyperbaric oxygen (HBO) therapy affects the expression levels of interleukin-12p40 (IL-12p40), macrophage inflammatory protein-1ß (MIP-1ß), platelet-derived growth factor-BB (PDGF-BB), and interleukin-1 receptor antagonist (IL-1Ra). OBJECTIVE: 30 patients were randomly selected and divided into the following 3 groups: keloid samples from keloid patients treated with HBO therapy (A), keloid samples from keloid patients treated without HBO therapy (B), and normal control skin samples derived from individuals who had no clear scarring (C). Each group included 10 samples. METHODS: Inflammatory factors in the keloid tissues were measured with the MILLIPLEX multiplexed Luminex system. Hematoxylin and eosin staining, immunohistochemical staining, and Western blotting were used to observe the morphological differences in different tissues and the expression levels. RESULTS: The expression levels of inflammatory mediators, including IL-12p40, MIP-1ß, PDGF-BB, and IL-1Ra, in keloid tissues were significantly different from those in samples of normal skin. Hematoxylin and eosin staining showed significantly greater inflammatory infiltration in keloid tissue. Significantly different expression levels were observed in group A, B, and C. CONCLUSION: Significantly altered levels of inflammatory factors in the samples from keloid patients were observed, suggesting that formation of a keloid is potentially related to inflammatory responses. HBO therapy could significantly affect the expression levels of IL-12p40, MIP-1ß, PDGF-BB, and IL-1Ra, indicating that the effects of HBO therapy are associated with the attenuation of inflammatory responses.


Assuntos
Becaplermina/metabolismo , Quimiocina CCL4/metabolismo , Oxigenação Hiperbárica/efeitos adversos , Subunidade beta 1 de Receptor de Interleucina-12/metabolismo , Queloide/terapia , Adulto , Feminino , Humanos , Oxigenação Hiperbárica/métodos , Proteína Antagonista do Receptor de Interleucina 1 , Queloide/metabolismo , Queloide/patologia , Masculino , Pessoa de Meia-Idade , Receptores de Interleucina-1/antagonistas & inibidores
8.
Cutis ; 105(1): 24-27, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32074152

RESUMO

Hyperbaric oxygen therapy (HOT) is a potentially useful technique for certain dermatologic conditions. We review its indications, dermatologic applications, and potential complications.


Assuntos
Dermatologia/métodos , Oxigenação Hiperbárica/métodos , Dermatopatias/terapia , Humanos , Oxigenação Hiperbárica/efeitos adversos , Dermatopatias/fisiopatologia
9.
Med Sci Sports Exerc ; 52(6): 1420-1426, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31876671

RESUMO

Hyperbaric oxygen therapy (HBOT) is a well-established treatment for a variety of conditions. Hyperbaric oxygen therapy is the administration of 100% oxygen breathing in a pressure vessel at higher than atmospheric pressure (1 atmosphere absolute = 101 kPa). Typically, treatment is given daily for between 1 and 2 h at pressures of 2.0 to 2.8 ATA, depending on the indication. Sporting injuries are often treated over 3 to 10 sessions. Hyperbaric oxygen therapy has been documented to be effective and is approved in 14 medical indications by the Undersea and Hyperbaric Medical Society, including, but not limited to, carbon monoxide poisoning, compromised skin grafts and flaps, crush injuries, necrotizing soft tissue infections, and nonhealing ulcers with arterial insufficiencies. Recently, HBOT for sports musculoskeletal injuries is receiving increased attention. Hyperbaric oxygen therapy may allow injured athletes to recover faster than normal rehabilitation methods. Any reduction in collegiate and professional athletes' rehabilitation period can be financially significant for top-level sports teams; however, further research is required to confirm HBOT's benefits on sports musculoskeletal injuries. The purpose of this review to discuss the current understanding of HBOT as a treatment modality for common musculoskeletal injuries in sport medicine. Moreover, we will highlight the advantages and disadvantages of this modality, as well as relevant clinical and research applications.


Assuntos
Traumatismos em Atletas/terapia , Oxigenação Hiperbárica , Sistema Musculoesquelético/lesões , Contusões/terapia , Humanos , Oxigenação Hiperbárica/efeitos adversos , Ligamentos/lesões , Mialgia/terapia , Consumo de Oxigênio , Entorses e Distensões/terapia , Traumatismos dos Tendões/terapia
10.
Diving Hyperb Med ; 49(4): 245-252, 2019 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-31828742

RESUMO

INTRODUCTION: A temporary myopic shift is a well-recognized complication of hyperbaric oxygen treatment (HBOT). Oxidation of proteins in the crystalline lens is the likely cause. Direct exposure of the eye to hyperbaric oxygen may exacerbate the effect. Our aim was to measure the magnitude of the myopic shift over a course of HBOT when using two different methods of oxygen delivery. METHODS: We conducted a randomised trial of oxygen delivery via hood versus oronasal mask during a course of 20 and 30 HBOT sessions. Subjective refraction was performed at baseline and after 20 and 30 sessions. We repeated these measurements at four and 12 weeks after completion of the course in those available for assessment. RESULTS: We enrolled 120 patients (mean age 57.6 (SD 11.2) years; 81% male). The myopic shift was significantly greater after both 20 and 30 sessions in those patients using the hood. At 20 treatments: refractory change was -0.92 D with hood versus -0.52 D with mask, difference 0.40 D (95% CI 0.22 to 0.57, P < 0.0001); at 30 treatments: -1.25 D with hood versus -0.63 with mask, difference 0.62 D (95% CI 0.39 to 0.84, P < 0.0001). Recovery was slower and less complete in the hood group at both four and 12 weeks. CONCLUSIONS: Myopic shift is common following HBOT and more pronounced using a hood system than an oronasal mask. Recovery may be slower and less complete using a hood. Our data support the use of an oronasal mask in an air environment when possible.


Assuntos
Oxigenação Hiperbárica , Miopia , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigenação Hiperbárica/instrumentação , Oxigenação Hiperbárica/métodos , Masculino , Máscaras , Pessoa de Meia-Idade , Miopia/etiologia , Oxigênio/administração & dosagem
11.
BMJ Open ; 9(11): e031135, 2019 11 18.
Artigo em Inglês | MEDLINE | ID: mdl-31740467

RESUMO

OBJECTIVES: To identify the risk factors related to the prognosis of carbon monoxide (CO)-poisoned patients in the hospital. DESIGN: Retrospective observational study. SETTING: Tri-Service General Hospital, Taiwan. METHODS: We conducted a review of the medical records of 669 CO-poisoned patients, who were admitted to the Department of Emergency, Tri-Service General Hospital, Taiwan, from 2009 to 2014. Demographic, clinical and laboratory data were collected for analysis. In the study, the end points for poor outcome were patients who either still had sequelae, were bedridden or died after treatment. The independent t-test, χ2 test and binary logistic regression were used to identify the association between the prognostic factors and the outcomes. RESULTS: The logistic regression analysis confirmed that the Glasgow Coma Scale (GCS) score (p=0.008) and blood urea nitrogen (BUN) (p=0.002) were related to poor outcomes. Furthermore, the receiver operating characteristic (ROC) curve showed that the cut-off point of intubation days was 1.5 days (area under the ROC curve [AUC]=0.793) for all patients and 2.5 days (AUC=0.817) for patients with intubation when predicting poor outcomes. CONCLUSION: We identified the factors that most strongly predict the prognosis of CO poisoning, including the GCS score, serum BUN and intubation days. Moreover, the number of hyperbaric oxygen treatments seems to have impact of the outcome.


Assuntos
Intoxicação por Monóxido de Carbono/mortalidade , Adulto , Intoxicação por Monóxido de Carbono/terapia , Comorbidade , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigenação Hiperbárica/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Curva ROC , Estudos Retrospectivos , Fatores de Risco , Tentativa de Suicídio/estatística & dados numéricos , Taiwan/epidemiologia , Adulto Jovem
12.
Mo Med ; 116(5): 396-399, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31645792

RESUMO

We are reporting a 52-year-old female that developed documented vision impairing, large, bilateral nuclear and cortical cataracts during therapy after 46 treatments of a planned 60 treatment course of HBO2 for a non-healing post-radiation leg wound. A review of the available literature makes this one of the earliest cases of cataract formation.


Assuntos
Catarata/etiologia , Oxigenação Hiperbárica/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Lesões por Radiação/terapia
13.
Diving Hyperb Med ; 49(3): 154-160, 2019 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-31523789

RESUMO

BACKGROUND: The risk of oxygen toxicity has become a prominent issue due to the increasingly widespread administration of hyperbaric oxygen (HBO) therapy, as well as the expansion of diving techniques to include oxygen-enriched gas mixtures and technical diving. However, current methods used to calculate the cumulative risk of oxygen toxicity during an HBO exposure i.e., the unit pulmonary toxic dose concept, and the safe boundaries for central nervous system oxygen toxicity (CNS-OT), are based on a simple linear relationship with an inspired partial pressure of oxygen (PO2) and are not supported by recent data. METHODS: The power equation: Toxicity Index = t2 × PO2c, where t represents time and c represents the power term, was derived from the chemical reactions producing reactive oxygen species or reactive nitrogen species. RESULTS: The toxicity index was shown to have a good predictive capability using PO2 with a power c of 6.8 for CNS-OT and 4.57 for pulmonary oxygen toxicity. The pulmonary oxygen toxicity index (PO2 in atmospheres absolute, time in h) should not exceed 250. The CNS-OT index (PO2 in atmospheres absolute, time in min) should not exceed 26,108 for a 1% risk. CONCLUSION: The limited use of this toxicity index in the diving community, after more than a decade since its publication in the literature, establishes the need for a handy, user-friendly implementation of the power equation.


Assuntos
Doenças do Sistema Nervoso Central/induzido quimicamente , Oxigenação Hiperbárica , Hiperóxia , Pneumopatias/induzido quimicamente , Oxigênio/toxicidade , Sistema Nervoso Central , Mergulho/fisiologia , Humanos , Oxigenação Hiperbárica/efeitos adversos , Pressão Parcial
14.
Diving Hyperb Med ; 49(3): 167-174, 2019 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-31523791

RESUMO

INTRODUCTION: Hyperbaric oxygen therapy (HBOT) involves the risk of central nervous system oxygen toxicity (CNS-OT), including seizures in patients breathing oxygen at pressures ≥ 2 atmospheres absolute. This study aimed to determine the seizure frequency and assess the clinical benefit of a 5-minute air-break (5´-AIRBK). METHODS: Twenty-year (1999-2018) retrospective analysis of all consecutive treatments with HBOT. Medical records were reviewed to determine patient demographics, comorbidities, HBOT indications, and seizure characteristics and timing. Seizure frequency was compared before and after incorporating a 5´-AIRBK in the treatment protocol. Chi-square testing was performed using SPSS (version 24.0); P < 0.05 was accepted as statistically significant. RESULTS: We evaluated 188,335 HBOT sessions (74,255 before versus 114,080 after introducing a 5´-AIRBK). A total of 43 seizures were observed: 29 before and 14 after the 5´-AIRBK introduction (3.9 versus 1.2 per 10,000 treatments; P < 0.0001). Seizures occurred after a median of 57 (range 15-85) minutes following compression and after a median of 21 HBOT sessions (1-126). Patients experiencing seizures were undergoing treatment for: diabetic ulcer (n = 11); acute traumatic peripheral ischaemia (ATPI) (n = 6); non-diabetic ulcer (n = 5); sudden sensorineural hearing loss (n = 5); chronic refractory osteomyelitis (n = 5); radionecrosis (n = 3); necrotising fasciitis (NF) (n = 2); and haemorrhagic cystitis after allogeneic bone marrow transplantation (n = 1). ATPI and NF had a considerably higher relative frequency of seizures compared to other indications. CONCLUSIONS: A statistically significant lower seizure frequency was achieved with a 5´-AIRBK. Assessing and defining the appropriate patient/treatment profile can be useful to minimise the risk of CNS-OT.


Assuntos
Oxigenação Hiperbárica , Convulsões/epidemiologia , Perda Auditiva Súbita , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigênio/efeitos adversos , Estudos Retrospectivos , Convulsões/etiologia
15.
Undersea Hyperb Med ; 46(4): 437-445, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31509900

RESUMO

Introduction: To determine if hyperbaric oxygen (HBO2) therapy has an effect on diabetic blood glucose levels (BGL) and, if so, the extent of this effect. Also, to examine factors that exacerbate any observed effect. Methods: This was a retrospective review of prospectively collected quality data on diabetics undergoing HBO2. Pre- and post-treatment BGL were recorded. Pre-treatment BGL ⟨120 mg/dL received glucose supplementation. Hypoglycemia was defined as BGL ⟨70 mg/dL. BGL ⟨90 mg/dL was included as an elevated hypoglycemia threshold. Results: 77 patients representing 1,825 treatments were included for analysis. No patient had deleterious side effects or required emergency care. BGL decreased in 75.4% of treatments in this group, with a median decrease of 25 mg/dL (IQR=54 mg/dL; range of decreased 374 mg/dL to increased 240 mg/dL). A statistically significant greater percentage of treatments of patients with type 2 diabetes resulted in a decrease in BGL (1598 or 77.5%) compared to treatments of patients with type 1 diabetes (169 or 51.5%) (χ2(1, N=1767) =55.37, p⟨0.001). 1.1% of treatments had post-HBO2 serum glucose ⟨90 mg/dL, and 0.2% of treatments had post-HBO2 serum glucose ⟨70 mg/dL. The majority (70%) of patients with post-HBO2 BGL ⟨90 mg/dL were maintained on insulin alone (χ2(2, N=20) =12.4, p=0.002). Well-controlled diabetics (i.e., those with all BGLs within 50 mg/dL over all pre-HBO2 treatments) had no post-HBO2 BGL ⟨70 mg/dL or ⟨90 mg/dL. Conclusion: Our results suggest that HBO2 does not cause a clinically significant decrease in diabetic patient BGL. No patient in our study had deleterious side effects or required emergency care. We found that glucose level of ⟨90 mg/dL occurred more often in those who use insulin. Hyperbaric patients who exhibit consistent BGL values may represent a group who could be managed similarly to the non-diabetic population.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Oxigenação Hiperbárica , Idoso , Diabetes Mellitus/induzido quimicamente , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Oxigenação Hiperbárica/estatística & dados numéricos , Hipoglicemia/sangue , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Estudos Retrospectivos , Esteroides/efeitos adversos
16.
Undersea Hyperb Med ; 46(4): 467-481, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31509903

RESUMO

Introduction/Background: The incidence of complications and number of critically ill patients in hyperbaric medicine is relatively low [1]. This poses a challenge to those tasked with educating trainees as well as maintaining the skills of staff. Hyperbaric medicine fellows may not be exposed to critical patient scenarios or complications of hyperbaric medicine during a one-year fellowship. Additional staff may be unfamiliar with these situations as well. The purpose of hyperbaric simulation curriculum is to train health care providers for rare situations. To our knowledge, this hyperbaric simulation curriculum is the first published use of simulation education in the specialty of undersea and hyperbaric medicine. Materials and Methods: Two simulation cases have been developed that involve a patient with oxygen toxicity during hyperbaric treatment as well as an ICU patient with mucous plugging. Results: Medical training simulations are an effective method of teaching content and training multiple roles in Undersea and Hyperbaric Medicine. Summary/Conclusions: A hyperbaric simulation curriculum is an achievable educational initiative that is able to train multiple team members simultaneously in situations that they may not encounter on a regular basis. We believe that this could be easily exported to otherinstitutions for further education.


Assuntos
Currículo , Educação Médica/métodos , Oxigenação Hiperbárica , Treinamento por Simulação/métodos , Doenças do Sistema Nervoso Central/induzido quimicamente , Doenças do Sistema Nervoso Central/terapia , Bolsas de Estudo , Humanos , Oxigenação Hiperbárica/efeitos adversos , Unidades de Terapia Intensiva , Intubação Intratraqueal , Muco , Oxigênio/envenenamento , Simulação de Paciente
17.
Lancet Oncol ; 20(11): 1602-1614, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31537473

RESUMO

BACKGROUND: Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis. METHODS: We did a randomised, controlled, phase 2-3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen-A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6-8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15. FINDINGS: Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210-262) in the hyperbaric oxygen therapy group and 217 days (195-237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2-18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy. INTERPRETATION: Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment. FUNDING: The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.


Assuntos
Braquiterapia/efeitos adversos , Cistite/terapia , Oxigenação Hiperbárica , Neoplasias Pélvicas/radioterapia , Doses de Radiação , Lesões por Radiação/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Cistite/diagnóstico , Cistite/etiologia , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Masculino , Pessoa de Meia-Idade , Neoplasias Pélvicas/patologia , Lesões por Radiação/diagnóstico , Lesões por Radiação/etiologia , Países Escandinavos e Nórdicos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
19.
Undersea Hyperb Med ; 46(3): 341-352, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31394603

RESUMO

Introduction: Global outcomes can strengthen inferences from clinical trials. We evaluate global outcomes for persistent post-concussive symptoms (PCS) after mild traumatic brain injury (mTBI) in two clinical trials of hyperbaric oxygen (HBO2) in United States service members. Methods: During study design, outcomes of symptom, cognitive, and functional impairments planned for a trial of HBO2 for PCS (HOPPS) were weighted and grouped into different domains to formulate the composite outcome total score. The composite outcome was compared between the intervention groups in HOPPS and those in a subsequent HBO2 trial (BIMA) for validation. Additionally, two post hoc global outcome measures were explored, including one composed of components that demonstrated favorable characteristics in both studies and another via components used in another TBI randomized trial (COBRIT). Results: In total, 143 active-duty or veteran military personnel were randomized across the two studies. Composite total scores improved from baseline for HBO2 (mean ± SD -2.9±9.0) and sham (-2.9±6.6) groups in HOPPS but did not differ significantly between groups (p=0.33). In BIMA, 13-week changes from baseline favored the HBO2 group (-3.6±6.4) versus sham (-0.3±5.2; p=0.02). No between-group differences were found when COBRIT composite scoring was applied to BIMA. Overall, HBO2 effects were maximized when the post hoc global measure derived from both studies was applied to the data. Conclusions: Composite total scores in HOPPS and BIMA were consistent with primary study results. The global measures considered may offer utility as endpoints to achieve maximal HBO2 effect in future trials of the mTBI population. IDs: clinicaltrials.gov Identifiers NCT01611194 (BIMA) and NCT01306968 (HOPPS).


Assuntos
Oxigenação Hiperbárica , Avaliação de Resultados em Cuidados de Saúde/métodos , Síndrome Pós-Concussão/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Concussão Encefálica/complicações , Cognição , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Masculino , Pessoa de Meia-Idade , Militares , Projetos de Pesquisa , Fatores de Tempo , Veteranos , Adulto Jovem
20.
Undersea Hyperb Med ; 46(3): 331-340, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31394602

RESUMO

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.


Assuntos
Oxigenação Hiperbárica/efeitos adversos , Síndrome Pós-Concussão/terapia , Adulto , Barotrauma/etiologia , Concussão Encefálica/complicações , Método Duplo-Cego , Dor de Orelha/etiologia , Feminino , Cefaleia/etiologia , Humanos , Oxigenação Hiperbárica/métodos , Masculino , Militares , Projetos Piloto , Distribuição Aleatória , Segurança
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