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Mask Ventilation With Different Face Masks During Neonatal Resuscitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01685697
First received: August 31, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Respiration; Insufficient or Poor, Newborn
Procedure: Mask ventilation with a Laerdal face mask
Procedure: Mask ventilation with a F&P face mask
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Round Face Masks During Neonatal Resuscitation

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Difference in percentage of Leak [ Time Frame: during mask ventilation in the first 5 minutes after birth ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: F&P Mask
Mask ventilation with a F&P 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.
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.

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.

  Eligibility

Ages Eligible for Study:   up to 30 Minutes
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685697

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