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

Newborn Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870622
• Other study ID #: Pro00036974
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: March 13, 2017
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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.

Related Conditions & MeSH terms

• Newborn Infant

Intervention

Procedure:
• Flow waves
Flow waves will be used to confirm correct tube placement in newborn infants.
• ECO2
ECO2 will be used to confirm correct tube placement in newborn infants.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Using flow waves will increase the percentage of correct tube placement in newborn infants	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.	within the first 10 inflations