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

Not Applicable

Completed

• Conditions: Delivery Room Resuscitation
• Interventions: Device: End tidal CO2 monitor

• Registration Number: NCT01381068
• Lead Sponsor: Neil Finer

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 Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-05
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Study Completion: 2011-09
• Results First Submitted: 2019-08-22
• Status Verified: 2019-10
• Results First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Results First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Need for ventilation in the delivery room

Exclusion Criteria

• Tracheal suctioning for meconium
• Congenital Diaphragmatic Hernia
• Suspected hypoplasia of the lungs
• Oligohydramnios <28 weeks gestation or AFI<5
• Known or suspected airway anomaly
• Mother not speaking English or Spanish
• Refusal of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitored Arm	End tidal CO2 monitor	The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.
Control Arm	End tidal CO2 monitor	The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.

Primary Outcome Measures

Name	Time	Method
PCO2 Level Outside of Desired Range (40-60 mmHg)	Admission to NICU, approximately 1 hour of life	This outcome will be obtained from the first available blood gas after admission to the NICU.

Secondary Outcome Measures

Name	Time	Method
Oxygen Use at 36 Weeks	Hospital course, approximately 2-3 months	This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.
Duration of Ventilation	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.
Incidence of Pneumothorax/Airleak	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.
Number of Patients Ventilated on NICU Admission	On NICU admission, approximately 15 minutes of life	At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow	Within 12 hours of life	An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.
End Tidal CO2 Levels	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.

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States