Overview

This trial is active, not recruiting.

Condition delivery room resuscitation
Treatment end tidal co2 monitor
Sponsor University of California, San Diego
Start date October 2009
End date May 2011
Trial size 50 participants
Trial identifier NCT01381068, 090780

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
end tidal co2 monitor NICO 2 Respiratory Profile Monitor (Respironics, Inc.)
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.
(Placebo Comparator)
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.
end tidal co2 monitor NICO 2 Respiratory Profile Monitor (Respironics, Inc.)
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.

Primary Outcomes

Measure
PCO2 level inside or outside of desired range (40-60 mmHg)
time frame: Admission to NICU, approximately 1 hour of life

Secondary Outcomes

Measure
End tidal CO2 levels
time frame: At the conclusion of resuscitation, approximately 15 minutes of life.
Duration of ventilation
time frame: Duration of the hospital course, approximately 2-3 months
Oxygen use at 36 weeks
time frame: Hospital course, approximately 2-3 months
Incidence of pneumothorax/airleak
time frame: Hospital course, approximately 2-3 months
Incidence of Severe IVH/PVL
time frame: Hospital Course, approximately 2-3 months
Ventilator Settings on NICU admission
time frame: On NICU admission, approximately 15 minutes of life
Systemic blood flow
time frame: Within 10 hours of life

Eligibility Criteria

Male or female participants up to 15 minutes old.

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

Additional Information

Official title Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?
Principal investigator Tina A Leone, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by University of California, San Diego.