Prevention of Morbidity in Sickle cell disease: Phase II (improvement of pain and quality of life in patients with sickle cell disease with auto-adjusting continuous positive airways pressure: Phase II) (POMS 2b)

niversity Hospital Southampton (UK)0 个研究点目标入组 60 人开始时间: 2015年7月2日最近更新: 2021年1月5日

适应症

试验速览

•1. Age >=8 years
•2. Informed consent with assent in accordance with the institutional policies (UK ethical committee) and European guidelines must be signed by the patient or patient's parent or legally authorised guardian acknowledging written consent to join the study. Patients < 16 years will be requested to give their assent to join the study
•3. HbSS diagnosed by standard techniques (HPLC, IEF and MS). Participating institutions must submit documentation of the diagnostic haemoglobin analysis
•4. Able to speak and understand English
•5. Patient or parent/guardian able to use smartphone app
•6. Overnight oximetry showing minimum overnight oxygen saturation of <94%

•1. Patient already on overnight respiratory support, or has used it in the past
•2. Hospital admission for acute sickle complication within the past 1 month
•3. Patient with >6 admissions for acute sickle complications within the past 12 months
•4. Existing respiratory failure
•5. Overnight oximetry showing mean overnight saturation of <90% for >30% of total measured time
•6. Severe sleep apnoea (OSA) defined by 4% ODI > 15/hr; Epworth sleepiness score >10
•7. Exclusions to APAP therapy:
•7.1. Decompensated cardiac failure
•7.2. History of severe epistaxis
•7.3. Trans-sphenoidal surgery, or trauma that could have left a cranio-nasopharyngeal fistula
•7.4. Perforated ear drum
•8. Bullous lung disease
•9. Bypassed upper airway
•10. Pneumothorax
•11. Patient at increased risk of aspiration
•12 Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when prescribing APAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus
•13. Pregnancy
•14. Patients on chronic blood transfusion regimes, or has had blood transfusion within past 3 months
•15. Any acute or chronic condition which would limit the patient’s ability to complete the study

发起方

niversity Hospital Southampton (UK)