Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial

Not Applicable

Completed

• Conditions: Newborn Infant
• Interventions: Procedure: ECO2; Procedure: Flow waves

• Registration Number: NCT01870622
• Lead Sponsor: University of Alberta

Brief Summary

Most premature babies have difficulty breathing at birth and need help (resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical team checks if the breathing tube is correctly placed within the windpipe. The investigators routinely use a detector which checks for exhaled carbon dioxide or the graphical display of waves forms of the infants breathing to check that the breathing tube position. However, the investigators do not know which one (exhaled carbon dioxide or the graphical display of waves forms) is better to check that the breathing tube position is correct and therefore the investigators would like to study them. The purpose of this study is to compare exhaled carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves group) to provide us with information on how the investigators can help babies who struggle with breathing at birth.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or neonatal intensive care unit will be recorded.

Exclusion Criteria

• Infants will also be excluded if their parents refuse to give consent to this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECO2	ECO2	ECO2 will be used to confirm correct tube placement in newborn infants.
Flow waves	Flow waves	Flow waves will be used to confirm correct tube placement

Primary Outcome Measures

Name	Time	Method
Using flow waves will increase the percentage of correct tube placement in newborn infants	within the first 10 inflations	Flow waves and exhaled Carbon dioxide will be compared using the numbers of inflation needed to identify correct tube placement.; We will compare the number of inflation in each group to identify which device can identify correct tube placement faster and more accurately.; Outcome will be number of inflation until correct tube placement has been identified.

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada