Clinical trial NCT01870622: Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial
Official title: Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Infant
Keywords: Newborn,
Infant,
Endotracheal Intubation,
Carbon dioxide detector,
Flow waves
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 100
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Using flow waves will increase the percentage of correct tube placement in newborn infants
timeFrame: within the first 10 inflations
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
References:
citation: Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.
citation: Schmolzer GM, Poulton DA, Dawson JA, Kamlin CO, Morley CJ, Davis PG. Assessment of flow waves and colorimetric CO2 detector for endotracheal tube placement during neonatal resuscitation. Resuscitation. 2011 Mar;82(3):307-12. doi: 10.1016/j.resuscitation.2010.11.008. Epub 2010 Dec 16.
citation: Schmolzer GM, Hooper SB, Crossley KJ, Allison BJ, Morley CJ, Davis PG. Assessment of gas flow waves for endotracheal tube placement in an ovine model of neonatal resuscitation. Resuscitation. 2010 Jun;81(6):737-41. doi: 10.1016/j.resuscitation.2010.02.018. Epub 2010 Mar 23.
citation: Aziz HF, Martin JB, Moore JJ. The pediatric disposable end-tidal carbon dioxide detector role in endotracheal intubation in newborns. J Perinatol. 1999 Mar;19(2):110-3. doi: 10.1038/sj.jp.7200136.
citation: Hosono S, Inami I, Fujita H, Minato M, Takahashi S, Mugishima H. A role of end-tidal CO(2) monitoring for assessment of tracheal intubations in very low birth weight infants during neonatal resuscitation at birth. J Perinat Med. 2009;37(1):79-84. doi: 10.1515/JPM.2009.017.
citation: O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Endotracheal intubation attempts during neonatal resuscitation: success rates, duration, and adverse effects. Pediatrics. 2006 Jan;117(1):e16-21. doi: 10.1542/peds.2005-0901.
citation: Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.