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A comparison of different round masks for intermittent positive pressure ventilation in preterm infants prior to intubation

In preterm infants receiving mask ventilation prior to elective ventilation, does a mask with a diameter that approximates the distance from the top of the infant’s nose to the bottom of their chin compared to the standard mask reduce leak between the infant’s face and t-piece resuscitation device (Neopuff)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000709640
Acronym
The MASK study
Enrollment
128
Registered
2014-07-04
Start date
2014-07-14
Completion date
Unknown
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

Preterm infants often need breathing support delivered through a mask placed on their faces (mask ventilation). Studies have shown that mask ventilation can be complicated by leak around the mask causing it to be less effective. Australian Resuscitation Council guidelines state ‘the appropriate size of face mask must seal around the mouth and nose but not cover the eyes or overlap the chin.’ A standard 50mm diameter soft round silicon mask (Laerdal 0/0) has been the mask of choice historically used at the Royal Women’s Hospital. However a recent study has shown that a smaller mask may comply better with guidelines. The aim of this study is to compare leak using a 50mm diameter mask compared to either 35mm (infants 26 weeks or less corrected gestational age) or 42mm ( 27 weeks or greater corrected gestational age) diameter masks (Fisher & Paykel neonatal resuscitation masks extra small or small). The study is a randomised controlled trial. The population is preterm infants less than 33 weeks gestation who require intubation while inpatient in the neonatal intensive care unit. The term intubation refers to the insertion of a breathing or endotracheal tube into the infant’s airway, so that they can be supported by a ventilator. Before the insertion of the tube, the infant receives premedication that sedates and gives pain relief but will cause the infant to stop breathing necessitating a predictable period of mask ventilation. The intervention group will receive either the 35 or 42mm mask to deliver mask ventilation, the control group the 50mm mask. The primary outcome is the difference in leak measured between the mask and the infant’s face between control and intervention groups.

Interventions

If mask ventilation is required prior to elective intubation, it will be performed using either the 35 or 42mm silicone Fisher & Paykel neonatal resuscitation masks. Infants less than 26 weeks post menstrual age will be allocated the 35mm mask and infants 27-32 weeks post menstrual age will be allocated the 42mm mask. The positive pressure ventilation will be performed by a Paediatric doctor.

Sponsors

Dr Lorraine McGrory
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
23 Weeks to 32 Weeks
Healthy volunteers
No

Inclusion criteria

Inpatient preterm infants less than 33 weeks post menstrual age requiring mask intermittent positive pressure ventilation before an elective intubation attempt with premedication.

Exclusion criteria

1. Infants in the delivery room or operating theatre who require endotracheal intubation will not be eligible for entry to this study. 2. Infants with a congenital anomaly of their face which may affect the ability of a mask to create a seal will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026