Mask Ventilation With Different Face Masks During Neonatal Resuscitation

• ClinicalTrials.gov Identifier: NCT01685697
• Recruitment Status: Completed
• First Posted: September 14, 2012
• Results First Posted: November 7, 2018
• Last Update Posted: November 7, 2018
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Respiration; Insufficient or Poor, Newborn	Procedure: Mask ventilation with a Laerdal face mask; Procedure: Mask ventilation with a F&P face mask	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Round Face Masks During Neonatal Resuscitation
• Study Start Date: March 2013
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Laerdal Mask; Mask ventilation with a Laerdal face mask	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.
Experimental: F&P Mask; Mask ventilation with a F&P face mask	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.

Outcome Measures

Primary Outcome Measures :

1. Difference in Percentage of Leak [ Time Frame: during mask ventilation in the first 5 minutes after birth ]
   Primary outcome: Difference in percentage of Leak

Eligibility Criteria

• Ages Eligible for Study: up to 30 Minutes (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Preterm infants <32 weeks gestation born at The Royal Alexandra Hospital who require resuscitation in the delivery room will be recorded.

Exclusion Criteria:

• Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.

Participants will be included in the first minutes after birth if they require mask ventilation for poor respiratory effort. Data will be collected from the Hospital chart until discharge at around 40 weeks gestation.

Contacts and Locations

Locations

Canada, Alberta

Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H 3V9

Sponsors and Collaborators

University of Alberta

Investigators

• Principal Investigator: Georg Schmolzer, MD,PhD; University of Alberta

More Information

Publications:

Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. Epub 2007 Nov 26.

Chua C, Schmölzer GM, Davis PG. Airway manoeuvres to achieve upper airway patency during mask ventilation in newborn infants - An historical perspective. Resuscitation. 2012 Apr;83(4):411-6. doi: 10.1016/j.resuscitation.2011.11.007. Epub 2011 Nov 18. Review.

Schmölzer GM, Morley CJ, Wong C, Dawson JA, Kamlin CO, Donath SM, Hooper SB, Davis PG. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012 Mar;160(3):377-381.e2. doi: 10.1016/j.jpeds.2011.09.017. Epub 2011 Nov 5.

Schmölzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT01685697
• Other Study ID Numbers: Pro00033526
• First Posted: September 14, 2012
• Results First Posted: November 7, 2018
• Last Update Posted: November 7, 2018
• Last Verified: January 2017