NCT01685697

Mask Ventilation With Different Face Masks During Neonatal Resuscitation

Comparison of Two Round Face Masks During Neonatal Resuscitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 30 Minutes
• Healthy volunteers: Not accepted

Summary

Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world. To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher \& Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital. The purpose of this study is to find out if one facemask is leaking less between the face and the mask.

Detailed description

We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher \& Paykel (FP) (Fisher \& Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask. The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher \& Paykel mask. A Respiratory Function Monitor will be placed between the face mask and the ventilation device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a face mask. This signal is automatically integrated to provide inspired and expired tidal volume. The difference equals the leak from the face mask. It also calculates respiratory rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration, temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at 200Hz using the Spectra physiological recording program (a customised neonatal respiratory physiology program). We will compare the % of mask leak within the two face masks.

Conditions

• Respiration; Insufficient or Poor, Newborn

Interventions

Type	Name	Description
PROCEDURE	Mask ventilation with a Laerdal face mask	Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.
PROCEDURE	Mask ventilation with a F&P face mask	Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-09-14
• Last updated: 2018-11-07
• Results posted: 2018-11-07

Locations

1 site across 1 country: Canada