A pilot study of hypertonic saline in children with chest infections and disabilities

Arm 1: Salbutamol (200 micrograms) via meter dose inhaler (Ventolin, Allen + Hanburys Respiratory Care), nebulised HTS (6%) 5ml pre-filled syringe (HyperSal6, sodium chloride, 60mg/mL, Royal Children’s Hospital Pharmacy Department), and chest physiotherapy The treatment order will be randomized and the administrators and participant will be blinded to the type of nebulisation a participant receives. The participant will receive four doses of nebulisation over the two day study period. These will occur in the morning and afternoon on both study days. The type of study nebulisation will vary between days according to the randomization sequence assigned to that participant. There will be the potential to do another two day cycle of the study period for those participants with longer admissions to PICU. Therefore a participant may complete a maximum of two cycles of the two day study period over the course of the trial. For these participants the total intervention period will be 4 days. Salbutamol will be administered immediately prior to each HTS nebulisation. Salbutamol and the study nebulisation will be administered two times a day prior to the morning and afternoon chest physiotherapy sessions. The nebulization will be delivered via standard pressurized air located at the participant’s bedside with a flow rate of 8 L/min. The nebuliser will be administered until the characteristic mist cannot be visualized and the nebuliser bowl is empty. The circuitry for delivery will be dependent on the type of ventilation a patient is receiving. Chest physiotherapy will commence within a maximum of 10 minutes after completion of the study nebulisation. Chest physiotherapy treatment has been flexibly defined approximating clinical reality for this heterogeneous participant group. Chest physiotherapy will include standard techniques of percussion, expiratory vibrations, manual hyperinflation, postural drainage, positioning and suction techniques. The chest physiotherapy administered for the participant’s initial chest physiotherapy intervention will be maintained across subsequent study periods where possible. Experienced physiotherapists from grade 1 to grade 4 will administer chest physiotherapy. No students will administer chest physiotherapy. Clinically the application of chest physiotherapy may differ between different therapists. Where possible the physiotherapist administering chest physiotherapy will be held constant between sessions to reduce this variability. A stop watch timer will be used to time chest physiotherapy interventions and ensure compliance with the time frame of the initial chest physiotherapy intervention. Participants with LRTI on PICU receive three chest physiotherapy sessions per day. All patients will receive three physiotherapy treatments in a day. Only two of these treatments, the morning and afternoon physiotherapy treatments will be included in the study. All participants will receive a third chest physiotherapy session in the evening. This was not included as part of the study intervention due to staffing limitations which would not allow adequate data collection during this period. Prior to the evening physiotherapy treatment, participants will receive a non-blinded normal saline nebuliser without salbutamol administration. A conservative washout period of approximately 18 hours or more, depending on the time of the afternoon treatment, will be utilized in the study to ensure no carry over effects. Adherence to the study protocol will be monitored by reviewing medication charts. Any study medications not used will be returned to the hospital pharmacy.