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

Study Overview
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Brief Summary
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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.

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

Conditions
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Delivery Room Resuscitation

Intervention / Treatment
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* Device: End tidal CO2 monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitored Arm<br>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. | Device: End tidal CO2 monitor<br>* 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.<br>* Other names: NICO 2 Respiratory Profile Monitor (Respironics, Inc.);|
| Placebo Comparator: Control Arm<br>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. | Device: End tidal CO2 monitor<br>* 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.<br>* Other names: NICO 2 Respiratory Profile Monitor (Respironics, Inc.);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Admission to NICU, approximately 1 hour of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Tidal CO2 Levels | The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome. | 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. | 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. | 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. | 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 | 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. | Within 12 hours of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation