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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870622
Enrollment
100
Registered
2013-06-06
Start date
2013-06-30
Completion date
2014-10-31
Last updated
2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Infant

Keywords

Newborn,, Infant,, Endotracheal Intubation,, Carbon dioxide detector,, Flow waves

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.

Interventions

PROCEDUREFlow waves

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

PROCEDUREECO2

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

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Using flow waves will increase the percentage of correct tube placement in newborn infantswithin the first 10 inflationsFlow 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026