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

NCT ID: NCT01870622

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Newborn Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ECO2

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

Group Type ACTIVE_COMPARATOR

ECO2

Intervention Type PROCEDURE

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

Flow waves

Flow waves will be used to confirm correct tube placement

Group Type EXPERIMENTAL

Flow waves

Intervention Type PROCEDURE

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

Interventions

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Flow waves

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

Intervention Type PROCEDURE

ECO2

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 23211476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21167628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20334964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10642970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18976048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16396845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15870667 (View on PubMed)

Other Identifiers

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Pro00036974

Identifier Type: -

Identifier Source: org_study_id

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