Clinical Trials Directory

Trials / Completed

CompletedNCT03431818

Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
University of Miami · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Detailed description

During routine nasal cannula (NC) use in the newborn ICU, the actual fraction of oxygen inspired by the infant, i.e. the effective FiO2 (Effective-FiO2) that reaches the infant's airways, cannot be easily determined. The effective FiO2 during NC use is generally lower than the FiO2 in the gas delivered by NC at the infant's nose due to dilution with ambient gas entrained by the infants during spontaneous inspiration. The factors influencing effective FiO2 include the set FiO2 of the gas delivered by NC (NC-FiO2), the NC-flow rate, and the entrainment of ambient gas by the infant during each spontaneous inspiration. The individual contribution of each of these factors to the variability in effective-FiO2 in extreme premature infants has not been systematically evaluated. The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Conditions

Interventions

TypeNameDescription
OTHERNasal cannula flow rateThis is a crossover study where observations will be obtained at five nasal cannula flow rates: 0.5, 1, 2, 4 and 6 liters per minute.

Timeline

Start date
2018-04-04
Primary completion
2023-01-01
Completion
2023-09-07
First posted
2018-02-13
Last updated
2025-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03431818. Inclusion in this directory is not an endorsement.