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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Ireland
  • Dublin 1, Ireland
    • The Rotunda Hospital
  • Dublin 8, Ireland
    • The Coombe Women & Infants University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente, Los Angeles Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants <72 hours of age and orally intubated

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Orally intubated infants; Subjects will be <72 hours of age and orally intubated. Following consent, four measures will be reported (i.e. body weight, nasal to tragus length, suprasternal notch to xyphoid process and shoulder to elbow length). Measures will be compared against a chest x-ray and placement of ETT at the subjects lip to identify the most accurate method to place endotracheal tubes in the newborn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Susan L Moran, DNP APRN NNP-BC FFNMRCSI, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Infant; Newborn; Intubation; Neonate; Neonatal resuscitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Cyanosis; Brief, Resolved, Unexplained Event
• Other Study ID Numbers: 14-1117; UL1TR001082 (U.S. NIH Grant/Contract)