Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study

Phase 4Not Yet RecruitingNCT07461272

University Hospital, Lille50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Suicide

Interventions

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 72 hours plus or minus 6 hours

Secondary Outcomes

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

Time frame: Montreal Cognitive Assessment Score at 6 months

Duration of mechanical ventilation

Time frame: 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

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

Number of adverse events

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