Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections

NCT07120581 | Active Not Recruiting

• 1 other identifier: 0160-24-ASF
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Invasive Fungal Infections; Hyperbaric Oxygen Therapy

Keywords

Hyperbaric Oxygen Therapy; Invasive Fungal Infection; Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Clinical Status on Discharge- ventilation status

  From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

• clinical status on discharge- kidney function

  From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

• clinical status on discharge- Kidney function

  From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

• clinical status on discharge- consciousness level

  From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

• clinical status on discharge- wound status

  From enrollment, baseline day 1, through study completion, an average of 4-8 weeks

Study Arms (1)

Hyperbaric Oxygen Therapy

Other: Hyperbaric Oxygen Therapy

Interventions

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.

Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to our health care facility (Shamir Medical Center) and diagnosed with invasive fungal infection

You may qualify if:

• at least 18 year old
• Trauma as the insult type causing the infection
• Refractory IFI with failure to respond to standard therapy (medical and surgical)
• Hyperbaric Oxygen Therapy as part of the treatment

You may not qualify if:

• Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
• Patients with immunosuppression background

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (3)

• 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.

  PMID: 33013472 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.

  PMID: 29229641 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.

  PMID: 34577787 BACKGROUND

MeSH Terms

Conditions

Invasive Fungal Infections; Wounds and Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Shai Efrati, M.D

  Assaf-Harofeh Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care Physician

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 13, 2025
• Study Start: August 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IL (1)