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The goal of this observational study is to learn about the effects of Hyperbaric Oxygen Therapy on healthy individual who suffer from invasive fungal infection caused by severe trauma, who do not respond to conventional treatment. The main question it aims to answer is:
Does the treatment aid in eradicating the infection and improve the overall outcome of such patients?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Other | Hyperbaric Oxygen Therapy at increasing pressure to 2.8 ATA for 2 hours sessions. Breaks of 5 every 20 minutes from the oxygen to air to avoid hyperoxia. Continued for the duration of the hospitalization in the ICU on a daily basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication of Fungal Infectious Agent | The time it takes from the start of treatments and until the first negative culture was found. | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status on Discharge- ventilation status | what support is the patient receiving upon discharge in terms of ventilation including invasive or non-invasive ventilation, need for oxygen or room-air | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| clinical status on discharge- kidney function |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to our health care facility (Shamir Medical Center) and diagnosed with invasive fungal infection
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| Name | Affiliation | Role |
|---|---|---|
| Shai Efrati, M.D | Assaf-Harofeh Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33013472 | Background | Arieli R, Aviner B. Acclimatization and Deacclimatization to Oxygen: Determining Exposure Limits to Avoid CNS O2 Toxicity in Active Diving. Front Physiol. 2020 Sep 4;11:1105. doi: 10.3389/fphys.2020.01105. eCollection 2020. No abstract available. | |
| 29229641 | Background | Dhingra S, Buckey JC, Cramer RA. Hyperbaric Oxygen Reduces Aspergillus fumigatus Proliferation In Vitro and Influences In Vivo Disease Outcomes. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01953-17. doi: 10.1128/AAC.01953-17. Print 2018 Mar. |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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the patient's kidney function assessed by presence of elevated Creatinine levels at discharge (mg\dl) |
| From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| clinical status on discharge- Kidney function | The patient's kidney function assessed by need for dialysis (yes/no) | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| clinical status on discharge- consciousness level | evaluation of the patient's consciousness level as either alert and responsive or still requiring sedation | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| clinical status on discharge- wound status | Whether the patient recieved a successful skin graft | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| clinical status on discharge- location of discharge | where were the patients discharged to- regular inpatient ward, a different medical center and which department (ICU or regular inpatient), rehabilitation center or not discharged (in case of death during the hospitalization). | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| Adverse Events | description of comlications occuring during the treatment, most notably seizures during the hyperbaric oxygen treatments | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks |
| 34577787 | Background | Ortega MA, Fraile-Martinez O, Garcia-Montero C, Callejon-Pelaez E, Saez MA, Alvarez-Mon MA, Garcia-Honduvilla N, Monserrat J, Alvarez-Mon M, Bujan J, Canals ML. A General Overview on the Hyperbaric Oxygen Therapy: Applications, Mechanisms and Translational Opportunities. Medicina (Kaunas). 2021 Aug 24;57(9):864. doi: 10.3390/medicina57090864. |