Isolated Medication plus Physiotherapy Airway Clearance Therapy in Kids with Chronic Suppurative Lung Diseases: A Randomised Controlled Trial (IM+PACT Kids: RCT)

The intervention consists of an airway clearance program prescribed by a physiotherapist with clinical experience in chronic respiratory disease management in children at the study site. Prescription of one or a combination of the following airway clearance programs, depending on age and ability of patient and carer. For children aged >2years, TherabubbleTM or Hydrapep (PEP) will be trialled at the initial consultation with the physiotherapist. In general, once the child is old enough to be able to coordinate undertaking PEP, this program will be prescribed preferentially over manual techniques. Where the child is unable to coordinate the PEP therapy (i.e., usually <2-years), manual techniques and/or active breathing techniques will be undertaken. The duration is 10-15minutes, twice a day, until 1-week post cough resolution. 1. TherabubbleTM or Hydrapep are TGA approved devices. Both devices are a form of positive expiratory pressure airway clearance. The duration is 10-15minutes, twice a day, until 1-week post cough resolution. The 10-15minute program includes sets of breaths for approximately 3-4 seconds exhalation. The physiotherapist may suggest sets of 5-10 sets of 10-15 breaths followed by huff and cough or time the sets for 3-5minutes each, depending on suitability with the patient again with each set being followed with huff and cough. 2. Manual techniques: Percussion is performed by the carer who has received instructions on the technique. The carer is taught how to undertake percussion in six possible positions. The carer is taught to undertake 10-15min twice a day. A huff (if able) and cough are encouraged at least three times during each session, if the child is old enough to understand. 3. Modified active breathing techniques: Deep breathing with active play using whistles, bubbles and balloons. The carer will be taught how to integrate active play with deep breathing with the use of bubbles, whistles and balloons for 10-15minutes twice daily. A huff (if able) and cough is encouraged at least three times during each session, if the child is old enough to understand. Note: Both Therabubble and Hydrapep are positive expiratory pressure therapies in the form of a plastic, multi-use (but for same patient only) bottle device. The bottle has a sealed lid, with a tubing (10mm diameter), which sits at the bottom of the bottle and then above the sealed lid so that the patient can blow into the tubing. The resistance with the apparatus is created by a water seal. The patient sits at a table and the bottle is filled to the correct level. The patient holds the tubing with one hand and then puts the end of the tubing in their mouth, seals the lips around the tubing and takes a slightly larger than tidal volume breath and breaths out for the 3-4 seconds. The patient is essentially blowing out against the resistance of the water, and this creates a "back pressure" or positive pressure which moves the secretions to where the patient can cough them up. All airway clearance programs will be taught in an outpatient clinic setting at either a hospital or private respiratory clinic. The duration of the teaching session will be a single session of 45minutes to 1-hour duration. Airway clearance will then be performed by the parent/carer independently at home each day for the duration specified by the physiotherapist. Strategies to assess adherence are a daily diary where the parent reports if airway clearance was performed and for how long.

The intervention consists of both: 1. Education provided to the parent/carer and child/adolescent on chronic wet cough recognition and the link to CLSD and bronchiectasis and the importance of antibiotic therapy to treat the cough. The physiotherapist will use the Perth Children’s Hospital “Chronic Lung Sickness flip chart” as a guide to assist with the explanation. Next the physiotherapist will explain the rationale for airway clearance therapy to clear mucus from the lungs. 2. A 28-day, twice daily 15-minute airway clearance program prescribed by a physiotherapist with clinical experience in chronic respiratory disease management in children at the study site. Written instructions are provided to the parent/carer. The airway clearance program prescribed will depend on the age and ability of the child. The program will be one of the following: 1. TherabubbleTM, hydrapep or Intersurgical PEP device: These TGA approved devices will be given to the participant. 2. Percussion in 6-positions (apical upper, apical lower, anterior, posterior, L side and R side) Percussion is with a cupped hand over the correct region (see Figure 3 below) for 5 minutes per region, with 3-postitions in the morning and 3-positions in the afternoon session. The baby/child is placed flat (or head up if reflux) and not tipped head down. 3. Modified active breathing techniques and active play (physical activity): A combination of “a” and “b” or just “a” or “b” can be undertaken for 15 minutes twice daily. “c” is integrated into deep breathing and active play techniques every 3–5-minute set. a. A series of deep breathing with or without the use of whistles, bubbles and balloons and tidal (controlled) breathing. The carer will be taught how to encourage deep breathing with the use of bubbles, whistles and balloons – usually about 3-5, followed by 3 tidal breaths. The participant continues this routine for a total of 5-minutes and completes three sets (of the 5-minutes) altogether. b. Active play. This can include skipping, dancing, ball/balloon games, running or trampoline bouncing to encourage spontaneous deep breathing for 3 sets of 5 minutes or 5 sets of 3 minutes (If mini tramp – carer holds child’s hand. If larger trampoline, only prescribed if has covered springs and safety netting. c. A huff (if able) and cough is encouraged at least three times during each session, if the child is old enough to understand. All airway clearance programs will be taught in an outpatient clinic setting at either a hospital or private respiratory clinic. The duration of the teaching session will be a single session of 45 minutes to 1-hour duration. Airway clearance will then be performed by the parent/carer independently at home each day for the duration specified by the physiotherapist. Parents will complete a daily diary reporting if airway clearance was performed and for how long to assess adherence to the intervention.