Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study

NCT07461272 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025/0204
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. The main objective of the study is to evaluate in patients who have attempted hanging without presenting cardio-respiratory arrest, the effect of one Hyperbaric Oxygen therapy session in addition to standard intensive care management on a potential reduction in short-term neurological sequelae. Patients will benefit from either standard management or standard management associated with one Hyperbaric Oxygen therapy session

Conditions

Suicide

Keywords

Hanging; Neurological sequelae; Hyperbaric oxygen therapy; Intensive care

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment Score

  The score can be interpreted as follows: ≥ 26/30 = no neurocognitive impairment 18-25/30 = mild impairment 10-17 = moderate impairment Less than 10 = severe impairment

  72 hours plus or minus 6 hours

Secondary Outcomes (4)

• Montreal Cognitive Assessment Score

  Montreal Cognitive Assessment Score at 6 months

• Duration of mechanical ventilation

  Participants will be monitored for duration of mechanical ventilation Participants will be monitored for duration of mechanical ventilation, an expected average of 24 hours

• Duration of hospital stay

  Participants will be monitored for duration of hospital stay, an expected average of 4 days.

• Number of adverse events

  Number of adverse effects during hospitalization, an expected average of 4 days.

Study Arms (2)

- Oxygèn

EXPERIMENTAL

Patients will receive standard intensive care management and an oxygen therapy session within 8 hours

Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL

- Control group

NO INTERVENTION

Patients will receive standard intensive care management only.

Interventions

OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL DRUG

In addition to standard intensive care management, patients will receive a hyperbaric oxygen therapy session within eight hours of admission to intensive care (the hyperbaric oxygen therapy session lasts two hours and must be completed eight hours after the hanging attempt).

- Oxygèn

Eligibility Criteria

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

You may qualify if:

• Patients who present, following an attempted hanging, neurological distress defined by the presence of one or more of the following criteria:
• Glasgow score \< 13/15
• Confusional syndrome
• Psychomotor agitation Who most of the time require optimal neuroprotection by sedation and invasive mechanical ventilation for the purpose of protecting the airways.
• Patient aged over 18 years,
• Suicide attempt by hanging without cardiocirculatory arrest,
• Patient insured socially and able to understand the information provided

You may not qualify if:

• Response time exceeded by \> 6 hours from the hanging
• Attempted hanging with immediate return to normal consciousness
• Patients and/or families unable to understand the information provided

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-03