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

Neil Finer50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Delivery Room Resuscitation

Interventions

End tidal CO2 monitorDEVICE

The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.

Eligibility

Sex: ALLMax age: 15 Minutes

Medical Language ↔ Plain English

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

Locations (1)

UCSD Medical Center

San Diego, California, United States

Outcomes

Primary Outcomes

PCO2 Level Outside of Desired Range (40-60 mmHg)

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

Time frame: Admission to NICU, approximately 1 hour of life

Secondary Outcomes

End Tidal CO2 Levels

The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.

Time frame: At the conclusion of resuscitation, approximately 15 minutes of life.

Duration of Ventilation

The number of days on the ventilator during the entire hospital course will be counted for this outcome.

Time frame: Duration of the hospital course, approximately 2-3 months

Oxygen Use at 36 Weeks

This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.

Time frame: Hospital course, approximately 2-3 months

Incidence of Pneumothorax/Airleak

This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.

Time frame: Hospital course, approximately 2-3 months

Number of Patients Ventilated on NICU Admission

At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group

Time frame: On NICU admission, approximately 15 minutes of life

Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow

An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.

Data from ClinicalTrials.gov

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