CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Mask ventilation with a Laerdal face mask +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01685697
NCT01685697N/ACompleted

Comparison of Two Round Face Masks During Neonatal Resuscitation

University of Alberta·interventional·Posted Sep 14, 2012·Updated Nov 7, 2018

In Brief

A clinical study evaluating Mask ventilation with a Laerdal face mask and Mask ventilation with a F&P face mask for Respiration; Insufficient or Poor, Newborn. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartMar 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.8 years ago

Interventions

Mask ventilation with a Laerdal face maskprocedure

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.

Mask ventilation with a F&P face maskprocedure

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.