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NCT05646875
A Comprehensive Evaluation of Hyperbaric Oxygen Therapy in Resuscitation Medicine - A Pilot Study (HOT-RESUS 1 Trial)
Conditions: Heart Arrest, Brain Injuries
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: University Hospital, Antwerp
Summary
In this prospective pilot study, the effects of hyperbaric oxygen therapy (HBOT) in post-cardiac arrest syndrome will be evaluated.
However, the primary outcome of this pilot study will be the feasibility of this approach.
If feasibility is determined, a larger study with adequate powering is to follow.
Eligibility Criteria
Depending on the study arm.ICU patients:Inclusion criteria: sustained ROSC since a maximum of 24 hours, hemodynamic and respiratory stable enough for transportation to HBOT.Exclusion criteria: traumatic CA, age <18 years, pregnancy, (tension-) pneumothorax.Healthy volunteers:Inclusion criteria: able to come to the study site themselves.
Exclusion criteria: age <18 years, (suspected or desired) pregnancy, known chronic illnesses, especially known claustrophobia, history of CA, history of pneumothorax, acute or chronic ear / nose condition.CA survivors after hospital discharge:Inclusion criteria: history of CA from hospital discharge up to a maximum of 3 years ago, able to come to the study site themselves.Exclusion criteria: age <18 years, (suspected or desired) pregnancy, known claustrophobia, history of pneumothorax, acute or chronic ear / nose condition.
Source: ClinicalTrials.gov (NCT05646875). StuddyBuddy aggregates publicly available trial information.