Oropharyngeal airway for prevention of airway obstruction during positive pressure ventilation in preterm infants < 34 weeks gestation during neonatal resuscitation - a randomised trial

For preterm infants born less than 34 weeks gestation requiring intermittent positive pressure ventilation in the delivery room, does the use of an oropharyngeal airway with a face mask reduce the prevalence of airway obstruction compared to using a face mask alone?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000392864

Enrollment

137

Registered

2012-04-05

Start date

2011-12-27

Completion date

2014-12-15

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Approximately 5-10% of newly born infants receive assistance in the delivery room to establish regular breathing. Healthcare workers provide artificial ventilation using a manual ventilation device and a face mask to fit around the infant’s nose and mouth. Several factors can reduce the effectiveness of mask ventilation. These include poor face mask application resulting in leak or airway obstruction and spontaneous movements of the baby. Airway obstruction may be due to inadvertent manual compression of the soft tissues of the neck, tongue and thus the trachea, or hyperextension or flexion of the head. In addition, if the face mask is held on the face too tight, it may obstruct the mouth and nose. Using a simple device such as an oropharyngeal airway may reduce the prevalence of obstruction during mask ventilation and lead to more effective mask ventilation. This randomized trial is investigating whether for newly born infants requiring positive pressure ventilation in the delivery room, does the use of an oropharyngeal airway with a face mask reduce the degree of airway obstruction compared to using a face mask alone. Physiological recordings of the resuscitation will be made measuring delivered and expired tidal volumes, prevalence and degree of airway obstruction as well as oxygen saturations and heart rate. Data will also be collected and compared between the groups on common neonatal morbidities including duration of assisted ventilation in the nursery.

Interventions

Use of an oropharyngeal airway during manual face mask intermittent positive pressure ventilation of newly born infants < 34 weeks gestation

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Infants less than 34 weeks gestation born in a tertiary level perinatal unit receiving IPPV in the DR with access to a respiratory function monitor.

Exclusion criteria

Infants born less than 34 weeks and not receiving active resuscitation. Infants with a known congenital anomaly. infants > 33 weeks gestation.

Outcome results