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

• ClinicalTrials.gov Identifier: NCT01870622
• Recruitment Status: Completed
• First Posted: June 6, 2013
• Last Update Posted: March 15, 2017
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Newborn Infant	Procedure: Flow waves; Procedure: ECO2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial
• Study Start Date: June 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ECO2; ECO2 will be used to confirm correct tube placement in newborn infants.	Procedure: ECO2; ECO2 will be used to confirm correct tube placement in newborn infants.
Experimental: Flow waves; Flow waves will be used to confirm correct tube placement	Procedure: Flow waves; Flow waves will be used to confirm correct tube placement in newborn infants.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: up to 120 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Alberta

Royal Alexandra Hospital

Edmonton, Alberta, Canada, T5H 3V9

Sponsors and Collaborators

University of Alberta

More Information

Publications:

Schmölzer 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. Review.

Schmölzer 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.

Schmölzer 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.

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.

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.

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.

Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT01870622
• Other Study ID Numbers: Pro00036974
• First Posted: June 6, 2013
• Last Update Posted: March 15, 2017
• Last Verified: March 2017

Keywords provided by University of Alberta:

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