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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT02181894
14-1117
UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

1 minute to 72 hours old

Volunteers

No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

Orally intubated infants
Description:
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.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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