Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Conditions

• Traumatic Spinal Cord Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Normobaric Hyperoxia — OTHER
  Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.

Study Details

SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.

Key Dates

Start date

Apr 15, 2026

Status verified

Feb 2026

Primary completion

Mar 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Intervention
  Normobaric hyperoxia

Primary Outcome Measure

Feasibility of early normobaric hyperoxic therapy [ Time Frame: 24 hours from injury ]

Central Contacts

• Andrew Kline
  352-273-9000
  [email protected]
• Ralisa Pop
  (352) 294-5693
  [email protected]

Locations (1)

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