Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study (SIPHON)

Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study / Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison

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

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide
• Intervention / Treatment: Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Response time exceeded by > 6 hours from the hanging
• Attempted hanging with immediate return to normal consciousness
• Refusal of consent from the family or trusted person at the time of inclusion in the study,
• Patients and/or families unable to understand the information provided

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: - Oxygèn; Patients will receive standard intensive care management and an oxygen therapy session within 8 hours	Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL; 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).
No Intervention: - Control group; Patients will receive standard intensive care management only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Intensive care; Hyperbaric oxygen therapy; Neurological sequelae; Hanging
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide
• Other Study ID Numbers: 2025/0204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No