N/A
N=25
Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
Pyloric Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03650842 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Cerebral Regional Oxygen Saturation (rSO2) — 81 percentage of oxygen
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Near infrared spectroscopy (NIRS) (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Regional Oxygen Saturation (rSO2) |
76 | — |
| PRIMARY Cerebral Regional Oxygen Saturation (rSO2) |
76 | — |
| PRIMARY Renal Regional Oxygen Saturation (rSO2) |
77 | — |
| PRIMARY Renal Regional Oxygen Saturation (rSO2) |
77 | — |
Summary
A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy, a device that is commonly used in our operating rooms to assess cerebral and tissue oxygenation.
Eligibility Criteria
Inclusion Criteria
- Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03650842). 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.