None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate the clinical effectiveness of LUS compared to routine chest physiotherapy outcome measures in determining the need for and effect of physiotherapy on neonates. This will be done by comparing whether LUS is better at guiding CPT treatment than looking at the lungs with CXR and listening to the lungs using a stethoscope. Results may help us improve how CPT is delivered to babies in the future.
Interventions
The purpose of this study is to evaluate the clinical effectiveness and feasibility of Lung Ultrasound (LUS) compared to routine CPT outcome measures of auscultation and CXR, in guiding decision-making around the use of CPT in neonates. Neonates will be considered for study eligibility as they are admitted to the Mater NICU. Recruited neonates will be consecutively enrolled over a 6-month period, accruing a minimum of 20 episodes. To investigate CPT for critically ill neonates, only participants identified as able to undergo CPT assessment along with having the possibility of re-assessment will be included. Further, as CPT plays a pivotal role in many of the neonates in the NICU and the possibility for multiple data collection episodes on a single participant, it is expected that the minimum episodes will be met to conduct a pilot study. Participants will undergo a routine assessment on admission by a trained neonatal physiotherapist using CXR, auscultation and evaluation of medical records. The assessment will be used to determine participant diagnosis and study eligibility. The physiotherapist will document the date and time that the participant underwent their CXR and what treatment they have received. At this stage, a CPT intervention plan will be determined. Participants will then undergo a LUS examination by an examiner blinded to the original assessment findings and diagnosis. This will be an efficient process, with participants examined in the position they present in to avoid any increased handling. Up to six lung regions will be assessed with a 10MHz linear probe, as outlined in Brat et al. (2015). These regions may include upper and lower quadrants of the anterior and posterior lung, and/ or the lateral quadrants of each hemithorax, depending on the position of the neonate at the time of assessment. LUS diagnosis and findings will be shared with the physiotherapist who provided the initial assessment and a re-evaluation of intended treatment will occur. If a change to treatment intervention is made, this will be undertaken by the initial, assessing physiotherapist. It is anticipated the LUS will take less than 10 minutes to complete and will be undertaken in whatever position the neonate presents in, meaning they will not be moved, or their position changed, in excess of their usual care. The LUS will occur during the neonate’s planned care time, thereby minimising any additional disruption or stress to the neonate. LUS scans will be undertaken by an advanced practice neonatal physiotherapist experienced in the management and handling of preterm and term born neonates. Where a neonate is deemed clinically unwell by the physiotherapist undertaking the LUS, discussion with the neonatologist will occur to ensure it is safe for the assessment to occur. As usual practice involves the assessment of all neonates by a physiotherapist in the NICU, regardless of gestation or birth weight, no limitations based on participant age or size will be imposed in this study. If a previously unidentified lung abnormality is found (e.g., pneumothorax), the neonatologist will be informed to ensure optimal treatment. Also, the time interference of an extra LUS measurement will be negated through prioritising emergency treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
Neonates who: • Are admitted to the NICU. • Require mechanically ventilated. • Are identified as meeting criteria for physiotherapy assessment. • Have had a CXR in the previous 24 hours Additionally, the parent/guardian must: o Have signed the consent form. o Be competent in understanding what the process will involve, assuring informed consent is obtained.
Exclusion criteria
• LUS not possible e.g. due to subcutaneous emphysema, dressings, wounds or skin integrity. • Expected discharge or back transfer <24 hours. • A plan for redirection of care.