Prevention of Morbidity in Sickle Cell Disease (POMS2a)—overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children

• DOI: 10.1186/s13063-019-3461-x
• Publication Date: 2019-07-18T11:02:54Z
• Authors: Jo Howard; Sophie A. Lee; Baba Inusa; Man Ying Edith Cheng; Cheema Bavenjit; Isabel C. Reading; Sally Ann Wakeford; Johanna C. Gavlak; Patrick B. Murphy; Nicholas Hart; Atul Gupta; Sati Sahota; Eufemia Jacob; Maria Chorozoglou; Carol Ossai; Maureen Gwam; Fenella J. Kirkham; Angela M. Wade; Christina Liossi
• Keywords: Crossover study; Positive airway pressure

This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and oxygen therapy (NOT) in adults children with sickle cell anaemia, patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, daily pain during interventions washout documented using tablet technology. Inclusion criteria were age > 8 years ability to use an iPad collect data. Trial participation was 4 weeks; week 1 involved baseline data collection 3 a between interventions, which administered for 7 days each weeks 2 order. Qualitative interviews transcribed verbatim analysed content funnelling technique, starting generally then gaining more detailed information on experience of both interventions. Safety routine haematology median period. Missing day values replaced multiple imputation. Ten (three female, 30.2 years, range 18–51.5 years) eleven (five 12 8.7–16.9 enrolled. Nine seven completed interviews. revealed that APAP machine smaller, easier handle, less noisy. Of 16 participants, 10 preferred (62.5%, 95% confidence interval (CI) 38.6–81.5%). Haemoglobin decreased from NOT (mean difference −3.2 g/L (95% CI −6.0 −0.2 g/L) −2.5 −4.6 0.3 g/L), respectively), but there no significant (NOT versus APAP, 1.1 (−1.2 3.6)). Pulmonary function changed little. Compared baseline, decreases number (1.58 1.71 NOT) comparing baseline. After adjustment carry-over period effects, non-significant 0.143 −0.116 0.401) additional NOT. In view point estimate preference or evidence worse after it decided proceed Phase II 6 months standard care further safety monitoring bone marrow suppression pain. ISRCTN46078697 . Registered 18 July 2014