Mask Ventilation With Different Face Masks During Neonatal Resuscitation

NCT01685697 | Completed Results DMC

• 1 other identifier: Pro00033526
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration; Insufficient or Poor, Newborn

Outcome Measures

Primary Outcomes (1)

• Difference in Percentage of Leak

  Primary outcome: Difference in percentage of Leak

  during mask ventilation in the first 5 minutes after birth

Study Arms (2)

Laerdal Mask

ACTIVE COMPARATOR

Mask ventilation with a Laerdal face mask

Procedure: Mask ventilation with a Laerdal face mask

F&P Mask

EXPERIMENTAL

Mask ventilation with a F\&P face mask

Procedure: Mask ventilation with a F&P face mask

Interventions

Mask ventilation with a Laerdal face mask PROCEDURE

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.

Laerdal Mask

Mask ventilation with a F&P face mask PROCEDURE

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.

F&P Mask

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (4)

• 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. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26.

  PMID: 18039750 BACKGROUND

• Chua C, Schmolzer 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.

  PMID: 22101203 BACKGROUND

• Schmolzer 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.

  PMID: 22056350 BACKGROUND

• Schmolzer 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.

  PMID: 20547584 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Georg Schmolzer
• Organization: Univeristy of Alberta

georg.schmoelzer@me.com

7807354660

Study Officials

• Georg Schmolzer, MD,PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 14, 2012
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2017-01

Locations

CA (1)