Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).

Completed

• Conditions: Infant Showing No Response to Resuscitation; Apparent Life Threatening Event in Newborn and Infant; Ventilator Adverse Event

• Registration Number: NCT02181894
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.

The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.

Hypothesis

Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Study Start: 2014-11
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Infants orally intubated and admitted into the Neonatal Intensive Care Unit.

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Exclusion Criteria

• Previous intubation
• Hydrops fetalis
• Thoracic congenital anomalies
• Facial abnormalities
• Naso-tracheal intubation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.	Up to 3 years

Trial Locations

Locations (5)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

The Rotunda Hospital; 🇮🇪 Dublin 1, Ireland

The Coombe Women & Infants University Hospital; 🇮🇪 Dublin 8, Ireland

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Kaiser Permanente, Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States