A Comprehensive Evaluation of Hyperbaric Oxygen Therapy in Resuscitation Medicine - a Pilot Study (HOT-RESUS 1 Trial)

NCT05646875 | Completed

• 1 other identifier: HOT-RESUS 1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Arrest; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study approach

  Successfully recruiting at least 10 patients in each of the 3 study arms

  8 months

Secondary Outcomes (1)

• Inflammation dynamics

  around 7 days (individual patient) / 8 months (study duration)

Study Arms (3)

post-ROSC

EXPERIMENTAL

patients directly post-ROSC receiving HBOT

Other: hyperbaric oxygen therapy

cardiac arrest survivors discharged home receiving HBOT

ACTIVE COMPARATOR

cardiac arrest survivors discharged home

Other: hyperbaric oxygen therapy

healthy volunteers receiving HBOT

ACTIVE COMPARATOR

healthy volunteers receiving HBOT

Other: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy OTHER

Hyperbaric oxygen therapy in a pressurized chamber, duration 1-2 hours at 2-3 ATA

cardiac arrest survivors discharged home receiving HBOT; healthy volunteers receiving HBOT; post-ROSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Healthy volunteers:
• CA survivors after hospital discharge:

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Heart Arrest; Brain Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Koen Monsieurs, Prof., MD

  University Hospital of Antwerp, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Koen Monsieurs, MD

Model Details: 3 groups: 1) post-ROSC patients 2) cardiac arrest survivors already discharged 3) healthy volunteers

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 12, 2022
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)