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

University of Alberta

Status: Completed

Conditions: Newborn Infant

Treatments: Procedure: ECO2; Procedure: Flow waves

Study type: Interventional

Funder types: Other

Identifiers

NCT01870622

Pro00036974

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: Under 120 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups

ECO2

Active Comparator group

Description:

ECO2 will be used to confirm correct tube placement in newborn infants.

Treatment:

Procedure: ECO2

Flow waves

Experimental group

Description:

Flow waves will be used to confirm correct tube placement

Treatment:

Procedure: Flow waves