Spinal cord Injury
Conditions
Brief summary
The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function
Detailed description
Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities.
Interventions
DRUGBaclofen Sintetica Intrathecaal 0
DRUG5 mg/ml oplossing voor infusie
Sponsors
Roessingh Centrum Voor Revalidatie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities. | — |
Countries
Netherlands
Outcome results
None listed