Clinical Trial: Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?

Brief Summary: This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.

Detailed Summary:
Sponsor: University of California, San Diego

Current Primary Outcome: PCO2 level inside or outside of desired range (40-60 mmHg) [ Time Frame: Admission to NICU, approximately 1 hour of life ]

This outcome will be obtained from the first available blood gas after admission to the NICU.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • End tidal CO2 levels [ Time Frame: At the conclusion of resuscitation, approximately 15 minutes of life. ]
    The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.
  • Duration of ventilation [ Time Frame: Duration of the hospital course, approximately 2-3 months ]
    The number of days on the ventilator during the entire hospital course will be counted for this outcome.
  • Oxygen use at 36 weeks [ Time Frame: Hospital course, approximately 2-3 months ]
    This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.
  • Incidence of pneumothorax/airleak [ Time Frame: Hospital course, approximately 2-3 months ]
    This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.
  • Incidence of Severe IVH/PVL [ Time Frame: Hospital Course, approximately 2-3 months ]
    This outcome will be counted as yes if the highest grade on any ultrasound done during hospitalization was Grade 3-4 or PVL was present on any ultrasound during the hospitalization.
  • Ventilator Settings on NICU admission [ Time Frame: On NICU admission, approximately 15 minutes of life ]
    The ventilator settings will be recorded at the time of NICU admission directly after the DR resuscitation.
  • Systemic blood flow [ Time Frame: Within 10 hours of life ]
    An echocardiogram performed within the first 10 hours of life will evaluate the right ventricular output (RVO), supervior vena cava (SVC) flow, patent ductus arteriosus and patent foramen ovale shunting. The SVC flow and RVO will be compared between groups.


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: June 21, 2011
Date Started: October 2009
Date Completion: September 2011
Last Updated: July 8, 2011
Last Verified: June 2011