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

NCT ID: NCT02181894

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan L Moran, DNP APRN NNP-BC FFNMRCSI

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

The Coombe Women & Infants University Hospital

Dublin, , Ireland

The Rotunda Hospital

Dublin, , Ireland

Countries

United States; Ireland

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1117

Identifier Type: -

Identifier Source: org_study_id