N/A
Completed N=49
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Delivery Room Resuscitation
Source: ClinicalTrials.gov NCT01381068 ↗
Enrolled (actual)
49
Serious AEs
6.3%
Results posted
Dec 2019
Primary outcomePrimary: PCO2 Level Outside of Desired Range (40-60 mmHg) — 9; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCO2 Level Outside of Desired Range (40-60 mmHg) |
9; 8 | — |
| SECONDARY End Tidal CO2 Levels |
42.8; 44.3 | — |
| SECONDARY Duration of Ventilation |
1; 1.5 | — |
| SECONDARY Oxygen Use at 36 Weeks |
3; 2 | — |
| SECONDARY Incidence of Pneumothorax/Airleak |
2; 2 | — |
| SECONDARY Number of Patients Ventilated on NICU Admission |
3; 4 | — |
| SECONDARY Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow |
83.7; 92.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01381068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.