Supplemental Oxygen Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2015 |
| Contact: | Michael Nageotte, MD |
| Email: | mnageotte@memorialcare.org |
| Phone: | 562-933-2730 |
The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at
10L/min via simple facemask to subjects receiving room air in those presenting for scheduled
cesarean sections.
10L/min via simple facemask to subjects receiving room air in those presenting for scheduled
cesarean sections.
Objective:
To compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask
to subjects receiving room air in those presenting for scheduled cesarean sections. The
investigators hypothesize that umbilical artery pH levels will not be significantly lowered
in the oxygenated group.
Primary outcome: umbilical artery pH levels in the oxygenated versus room air group
Secondary outcomes: Apgars, respiratory distress syndrome, necrotizing enterocolitis,
interventricular hemorrhage, intubation, number of NICU days and neonatal mortality.
Methods:
Only term elective c-sections will be approached for study consent. Once enrolled subjects
will be randomized either receive 10L/min via simple facemask or to room air. Once regional
anesthesia is completed, then the facemask with oxygen will be placed. The time from oxygen
administration to uterine incision will be at least 10 min. At the time of delivery
umbilical cord gases will be collected by and will be processed within one hour of delivery.
Inclusion criteria:
- 18 years or older
- Scheduled cesarean section
- Singleton
- Term gestation; at 37 0/7 weeks gestation or greater
Exclusion criteria:
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
- Fetal anomalies
- Breech position
- Multiple Gestation
Statistical analysis:
Subjects will be randomized via block randomization. The estimated umbilical arterial pH in
the scheduled cesarean section room air group is 7.31. To identify a 0.05 or greater
difference between the control and treatment group, a power of 0.8, alpha of 0.05 the
investigators would need 64 subjects total. To account for drop out the investigators intend
to enroll a total of 70 subjects.
To compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask
to subjects receiving room air in those presenting for scheduled cesarean sections. The
investigators hypothesize that umbilical artery pH levels will not be significantly lowered
in the oxygenated group.
Primary outcome: umbilical artery pH levels in the oxygenated versus room air group
Secondary outcomes: Apgars, respiratory distress syndrome, necrotizing enterocolitis,
interventricular hemorrhage, intubation, number of NICU days and neonatal mortality.
Methods:
Only term elective c-sections will be approached for study consent. Once enrolled subjects
will be randomized either receive 10L/min via simple facemask or to room air. Once regional
anesthesia is completed, then the facemask with oxygen will be placed. The time from oxygen
administration to uterine incision will be at least 10 min. At the time of delivery
umbilical cord gases will be collected by and will be processed within one hour of delivery.
Inclusion criteria:
- 18 years or older
- Scheduled cesarean section
- Singleton
- Term gestation; at 37 0/7 weeks gestation or greater
Exclusion criteria:
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
- Fetal anomalies
- Breech position
- Multiple Gestation
Statistical analysis:
Subjects will be randomized via block randomization. The estimated umbilical arterial pH in
the scheduled cesarean section room air group is 7.31. To identify a 0.05 or greater
difference between the control and treatment group, a power of 0.8, alpha of 0.05 the
investigators would need 64 subjects total. To account for drop out the investigators intend
to enroll a total of 70 subjects.
Inclusion Criteria:
- 18 years or older
- Scheduled cesarean section
- Singleton
- Term gestation
Exclusion Criteria:
- Maternal lung disease including asthma
- Evidence of hypoxemia prior to enrollment
- Intrauterine growth restriction
- Chronic hypertension
- Preeclampsia
- Fetal anomalies
- Breech position
- Multiple gestation
We found this trial at
1
site
Long Beach, California 90806
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