RecruitingACTRN12622001009707

The relationship between lung ultrasound imaging and oxygenation during alveolar recruitment manoeuvres in neonates receiving high frequency oscillatory ventilation.


Sponsor

The Royal Women's Hospital

Enrollment

20 participants

Start Date

Jan 18, 2023

Study Type

Observational

Conditions

Summary

Babies often require help to breath from a breathing machine (mechanical ventilation with a ventilator). While this keeps babies alive, it may damage their lungs. To minimise this damage, we use gentle methods of mechanical ventilation. High frequency oscillatory ventilation (HFOV) is an alternative type of mechanical ventilation thought to cause less lung damage. To use this type of breathing support safely, a baby’s lungs need to be properly inflated. We usually find out this information by using x-rays of a baby’s lungs, oxygen levels, and measurements we get from the ventilator. Babies whose lungs are not fully inflated need more pressure from the ventilator to open up their lungs, but it can be hard to know when we have given enough pressure. Lung x-rays give us some information about how well inflated the lungs are, but they use radiation and only provide a picture at one point in time. As a result, we rely on a baby’s oxygen levels and measurements from the ventilator to guide how we open the lungs with pressure. These are not very accurate. Ultrasound and electrical impedance tomography (EIT) are forms of imaging that do not use radiation. Ultrasound uses reflected sound to create an image of different parts of the body. EIT uses changes in electrical resistance to create images of the lung. Both are safe, painless and can be used to assess lung inflation over a period of minutes rather than a single time point like x-rays do. We are exploring whether a lung ultrasound performed during a procedure to inflate the lungs called a “recruitment manoeuvre” can help us find the best pressure to use to keep the lungs properly inflated. In this study, we will perform ultrasounds of a baby’s lungs at each step during a recruitment manoeuvre. We will compare the lung ultrasound findings to the usual ways we measure the lung inflation and also to measurements of lung inflation from EIT. These findings may help us better use HFOV in the future.


Eligibility

Sex: Both males and femalesMax Age: 4 Monthss

Plain Language Summary

Simplified for easier understanding

Premature and critically ill newborns often need help breathing from a ventilator. High frequency oscillatory ventilation (HFOV) is a gentler form of mechanical ventilation thought to cause less lung damage — but to use it safely, the baby's lungs need to be properly inflated, which can be hard to assess accurately. Currently, doctors use X-rays, oxygen levels, and ventilator readings to guide lung inflation — but these methods are imprecise and X-rays expose babies to radiation. This study tests whether lung ultrasound — which uses harmless sound waves — can help doctors find the ideal pressure setting to keep a baby's lungs properly inflated during a procedure called an alveolar recruitment manoeuvre. Ultrasound images of the lungs are taken at each step of the procedure and compared against electrical impedance tomography (another radiation-free method) and standard clinical measures. Your baby may be eligible if they are a newborn receiving high frequency oscillatory ventilation with a condition such as respiratory distress syndrome, pneumonia, or meconium aspiration. Babies with certain conditions — such as congenital diaphragmatic hernia, pulmonary hypertension, or a pneumothorax — are not eligible, as increasing lung pressure would not be safe for them.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Infants who are ventilated on high frequency oscillatory ventilation (HFOV) will receive an oxygenation guided alveolar recruitment manoeuvre (ARM) if deemed appropriate and required by the treating t

Infants who are ventilated on high frequency oscillatory ventilation (HFOV) will receive an oxygenation guided alveolar recruitment manoeuvre (ARM) if deemed appropriate and required by the treating team. ARMs are standard procedure when practicing open lung protective ventilation strategies. The number of increments of the ARM will vary as it is guided by the infants response to the procedure. Lung ultrasound (LUS) will be performed at each step of the recruitment manoeuvre. The number of ultrasound will vary depending on number of steps in the recruitment manoeuvre. This is anticipated to be between 5 to 15. Each ultrasound is anticipated to take 3 minutes. If a system is available, electrical impedance tomography (EIT) will be performed to concurrently measure end expiratory lung volume (EELV) throughout the manoeuvre. Ultrasound and EIT findings will not be used to guide clinical treatment and the treating team will be blinded to the findings. Demographic data, ventilation and physiological parameters will be collected during the ARM period. No follow up data will be collected.


Locations(3)

The Royal Women's Hospital - Parkville

VIC, Australia

The Royal Childrens Hospital - Parkville

VIC, Australia

Sunshine Hospital - St Albans

VIC, Australia

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