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

Study Overview
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Brief Summary
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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.

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

Conditions
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Newborn Infant

Intervention / Treatment
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* Procedure: Flow waves
* Procedure: ECO2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECO2<br>ECO2 will be used to confirm correct tube placement in newborn infants. | Procedure: ECO2<br>* ECO2 will be used to confirm correct tube placement in newborn infants.<br>|
| Experimental: Flow waves<br>Flow waves will be used to confirm correct tube placement | Procedure: Flow waves<br>* Flow waves will be used to confirm correct tube placement in newborn infants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using flow waves will increase the percentage of correct tube placement in newborn infants | 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. | within the first 10 inflations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn,, Infant,, Endotracheal Intubation,, Carbon dioxide detector,, Flow waves