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OpenTrials
Completed

NCT Number: NCT01870622

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

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.

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Key information

Conditions

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow waves

Procedure

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

ECO2

Procedure

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

Primary outcomes

  1. Using flow waves will increase the percentage of correct tube placement in newborn infants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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