N/A
N=49
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Delivery Room Resuscitation
Bottom Line
View on ClinicalTrials.gov: NCT01381068 ↗Enrolled (actual)
49
Serious AEs
6.3%
Results posted
Dec 2019
Primary outcome: Primary: PCO2 Level Outside of Desired Range (40-60 mmHg) — 9; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- End tidal CO2 monitor (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Neil Finer
- Primary completion
- May 2011
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 | — |
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.
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.