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

NCT02181894 | Completed DMC

• 2 other identifiers: 14-1117UL1TR001082
• Study Type: observational
• Target: 8
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Keywords

Infant; Newborn; Neonate; Intubation; Neonatal resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Minute - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants \<72 hours of age and orally intubated

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (5)

Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

The Coombe Women & Infants University Hospital

Dublin, Ireland

Location

The Rotunda Hospital

Dublin, Ireland

Location

Study Officials

• Susan L Moran, DNP APRN NNP-BC FFNMRCSI

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

IE (2); US (3)