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

Neil Finer

Status: Completed

Conditions: Delivery Room Resuscitation

Treatments: Device: End tidal CO2 monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01381068

090780

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: Under 15 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Monitored Arm

Experimental group

Description:

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.

Treatment:

Device: End tidal CO2 monitor

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Device: End tidal CO2 monitor