In very preterm infants who are being extubated to nasal continuous positive airway pressure (CPAP), does a continuous positive airway pressure (CPAP) recruitment maneuvre post extubation improve global and regional end-expiratory lung volume, thoracoabdominal asynchrony and work of breathing when compared to no recruitment maneuvre?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000167066

Acronym

The CPAP Study

Enrollment

Registered

2010-02-19

Start date

2010-02-20

Completion date

2013-02-28

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Very preterm infants are particularly susceptible to ventilator induced lung injury and methods of non-invasive respiratory support, the commonest being CPAP are known to reduce the risk of lung injury. However, the optimal pressure levels remain to be determined. Will very preterm infants with respiratory distress syndrome who are being extubated to CPAP initially need higher CPAP pressures than are usually used in order to restore and maintain lung volume? Our hypothesis is that infants extubated to nasal CPAP will initially need higher CPAP pressures than the mean airway pressure delivered by the ventilator prior to extubation in order to restore and maintain lung volume

Interventions

A randomised controlled trial comparing a CPAP recruitment maneuvre in very preterm infants < 32weeks gestation who are being extubated to nasal CPAP. Eligible infants randomised to a CPAP recruitment maneuvre will be extubated to a CPAP pressure of 6cmH2O.This will be increased to a CPAP pressure of 8cm H2O and then 10 cm H2O over 5 mins. The infant will be maintained at 10 cm H2O for 15 mins before being returned to CPAP pressure of 6cmH2O. This maneuvre will only occur once post extubation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

24 Weeks to 32 Weeks

Healthy volunteers

Inclusion criteria

Ventilated infants less than 32 weeks gestational age who are being extubated to nasal CPAP who have an inspired fraction of oxygen (FiO2) requirement < 0.4 to maintain saturations 88-92%

Exclusion criteria

Infants will be excluded if they are at risk of being intubated secondary to increasing FiO2 requirements or have multiple episodes of apnoea requiring stimulation; are at risk of being intubated in the next 2-3 hours post-extubation; are receiving NIPPV (non-invasive positive pressure ventilation; have a major congenital anomaly that might have an adverse effect on breathing or ventilation, apart from prematurity or asphyxia; are too unstable for routine nursing and have skin that is too fragile for conventional ECG electrode placement

Outcome results