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

Ventilator Adverse Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181894
• Other study ID #: 14-1117
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: November 2014
• Est. completion date: July 1, 2016

Study information

• Verified date: July 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous intubation

• Hydrops fetalis

• Thoracic congenital anomalies

• Facial abnormalities

• Naso-tracheal intubation

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Ireland	The Rotunda Hospital	Dublin 1
Ireland	The Coombe Women & Infants University Hospital	Dublin 8
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	Kaiser Permanente, Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Countries where clinical trial is conducted

United States,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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