CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Flow waves +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01870622
NCT01870622N/ACompleted

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

University of Alberta·interventional·Posted Jun 6, 2013·Updated Mar 15, 2017

In Brief

A clinical study evaluating Flow waves and ECO2 for Newborn Infant. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNewborn Infant
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 6, 2013
Enrollment StartJun 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.1 years ago

Interventions

Flow wavesprocedure

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

ECO2procedure

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