Pyloric Stenosis
Conditions
Brief 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.
Detailed description
This prospective study will include 50 patients under the age of 18 years who are having laparoscopic pyloromyotomy. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS). Prior to anesthetic induction, the NIRS monitor will be placed on the forehead. The device is non-invasive like pulse oximetry using a non-painful adhesive sticker. The device can be applied to different sites on the body to measure cerebral, tissue or even organ oxygenation. For the purpose of the study, the investigators will place one monitor on the forehead to measure tissue oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation. These devices are used routinely in the operating room and the cardiothoracic intensive care unit for cardiac patients. Although not used on every surgical procedure, NIRS monitoring can be used on all patients who are undergoing major surgical procedures. Tissue and cerebral oxygenation will be recorded continuously starting just prior to anesthetic induction until the completion of the procedure.
Interventions
One monitor will be placed on the forehead to measure cerebral oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Regional Oxygen Saturation (rSO2) | At time of incision | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead. |
| Renal Regional Oxygen Saturation (rSO2) | At time of incision | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Pyloromyotomy Patients undergoing laparoscopic pyloromyotomy. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Laparoscopic Pyloromyotomy | — |
|---|---|---|
| Age, Continuous | 40 days STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
| Weight | 4 kilograms STANDARD_DEVIATION 0.6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Cerebral Regional Oxygen Saturation (rSO2)
Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.
Time frame: At time of incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Pyloromyotomy | Cerebral Regional Oxygen Saturation (rSO2) | 81 percentage of oxygen | Standard Deviation 12 |
Primary
Cerebral Regional Oxygen Saturation (rSO2)
Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.
Time frame: At the end of laparoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Pyloromyotomy | Cerebral Regional Oxygen Saturation (rSO2) | 76 percentage of oxygen | Standard Deviation 16 |
Primary
Renal Regional Oxygen Saturation (rSO2)
Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.
Time frame: At time of incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Pyloromyotomy | Renal Regional Oxygen Saturation (rSO2) | 83 percentage of oxygen | Standard Deviation 11 |
Primary
Renal Regional Oxygen Saturation (rSO2)
Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.
Time frame: At the end of laparoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Pyloromyotomy | Renal Regional Oxygen Saturation (rSO2) | 77 percentage of oxygen | Standard Deviation 20 |