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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study.
Journal of Pediatrics 2016 January
OBJECTIVE: To compare the time spent within a predefined safe range of CO2 (30-60 mmHg) during conventional ventilation between infants who were monitored with distal end-tidal CO2 (dETCO2, or capnography) and those who were not.
STUDY DESIGN: For this randomized, controlled multicenter study, ventilated infants with a double-lumen endotracheal tube were randomized to 1 of 2 groups: the open (monitored) group, in which data from the capnograph were recorded, displayed to the medical team, and used for patient care, and the masked group, in which data from the capnograph were recorded. However, the measurements were masked and not available for patient care. dETCO2 was compared with PaCO2 measurements recorded for patient care.
RESULTS: Fifty-five infants (25 open, 30 masked) participated in the study (median gestational age, 28.6 weeks; range, 23.5-39.0 weeks). The 2 groups were comparable. dETCO2 was in good correlation (r = 0.73; P < .001) and adequate agreement (mean ± SD of the difference, 3.0 ± 8.5 mmHg) with PaCO2. Compared with infants in the masked group, those in the monitored group had significantly (P = .03) less time with an unsafe dETCO2 level (high: 3.8% vs 8.8% or low: 3.8% vs 8.9%). The prevalence of intraventricular hemorrhage or periventricular leukomalacia rate was lower in the monitored group (P = .02) and was significantly (P < .05) associated with the independent factors dETCO2 monitoring and gestational age.
CONCLUSION: Continuous dETCO2 monitoring improved control of CO2 levels within a safe range during conventional ventilation in a neonatal intensive care unit.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT01572272.
STUDY DESIGN: For this randomized, controlled multicenter study, ventilated infants with a double-lumen endotracheal tube were randomized to 1 of 2 groups: the open (monitored) group, in which data from the capnograph were recorded, displayed to the medical team, and used for patient care, and the masked group, in which data from the capnograph were recorded. However, the measurements were masked and not available for patient care. dETCO2 was compared with PaCO2 measurements recorded for patient care.
RESULTS: Fifty-five infants (25 open, 30 masked) participated in the study (median gestational age, 28.6 weeks; range, 23.5-39.0 weeks). The 2 groups were comparable. dETCO2 was in good correlation (r = 0.73; P < .001) and adequate agreement (mean ± SD of the difference, 3.0 ± 8.5 mmHg) with PaCO2. Compared with infants in the masked group, those in the monitored group had significantly (P = .03) less time with an unsafe dETCO2 level (high: 3.8% vs 8.8% or low: 3.8% vs 8.9%). The prevalence of intraventricular hemorrhage or periventricular leukomalacia rate was lower in the monitored group (P = .02) and was significantly (P < .05) associated with the independent factors dETCO2 monitoring and gestational age.
CONCLUSION: Continuous dETCO2 monitoring improved control of CO2 levels within a safe range during conventional ventilation in a neonatal intensive care unit.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT01572272.
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