Health TrialsbyHealthPanel

Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study

ConditionSuicide
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: - OxygènExperimental treatment 1 intervention
Group B: - Control groupNo intervention 0 interventions

Trial outcomes

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

Time frame
72 hours plus or minus 6 hours

Secondary 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

Time frame
Montreal Cognitive Assessment Score at 6 months
2

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
3

Duration of hospital stay

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

Number of adverse events

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: