Phase 3
N=13
Inhaled Nitric Oxide in Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03260569 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: PaO2 — 115; 95 mmHg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inhaled Nitric Oxide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PaO2 |
115; 95 | <0.05 sig |
Summary
This study will evaluate the changes in respiratory mechanics following traumatic brain injury and determine the effect of inhaled nitric oxide on gas exchange.
Eligibility Criteria
Inclusion Criteria
- Hospital admission with traumatic brain injury (penetrating or blunt)
- Requirement for mechanical ventilation
- Glasgow Coma Score > 3
Exclusion Criteria
- Brain death
- Expected survival 0.65
- Hemodynamic instability (systolic blood pressure 20 mm Hg)
- Spinal cord injury with hypotension
- Severe acute respiratory distress syndrome (ARDS) (PaO2/FiO2 3
- First rib fracture
- Flail chest
Data sourced from ClinicalTrials.gov (NCT03260569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.