- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650842
Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
November 19, 2019 updated by: Joseph D. Tobias, Nationwide Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laparoscopic pyloromyotomy
Infants undergoing laparoscopic pyloromyotomy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Regional Oxygen Saturation (rSO2)
Time Frame: 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.
|
At time of incision
|
Cerebral Regional Oxygen Saturation (rSO2)
Time Frame: At the end of laparoscopy
|
Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.
|
At the end of laparoscopy
|
Renal Regional Oxygen Saturation (rSO2)
Time Frame: 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.
|
At time of incision
|
Renal Regional Oxygen Saturation (rSO2)
Time Frame: At the end of laparoscopy
|
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.
|
At the end of laparoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2017
Primary Completion (Actual)
October 8, 2018
Study Completion (Actual)
October 8, 2018
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
December 6, 2019
Last Update Submitted That Met QC Criteria
November 19, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB16-00199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pyloric Stenosis
-
Bnai Zion Medical CenterUnknownSpinal Anesthesia | General Anesthesia | Hypertrophic Pyloric Stenosis
-
Children's Mercy Hospital Kansas CityCompletedHypertrophic Pyloric StenosisUnited States
-
Sheba Medical CenterUniversity of HaifaUnknownHealthy | Hypertrophic Pyloric Stenosis
-
Centre Hospitalier Universitaire, AmiensRecruitingRespiratory Complication | Hypertrophic Pyloric StenosisFrance
-
Shanghai Zhongshan HospitalUnknownInfantile Hypertrophic Pyloric Stenosis | PyloromyotomyChina
-
Institute of Child HealthTerminated
-
Chinese University of Hong KongCompletedGastric Outlet ObstructionHong Kong
-
Arlyne ThungCompletedPyloric StenosisUnited States
-
Cook Group IncorporatedMED Institute, Incorporated; Cook EndoscopyTerminatedGastric Outlet ObstructionNetherlands, Belgium, Italy
-
Maimonides Medical CenterCompletedPyloric StenosisUnited States
Clinical Trials on Near infrared spectroscopy (NIRS)
-
Brigham and Women's HospitalUnknownHypoxia | Infant, Premature, Diseases | Necrotizing EnterocolitisUnited States
-
University of AthensRecruitingCOVID-19 Pneumonia | COVID-19 Acute Respiratory Distress SyndromeGreece
-
Centre Hospitalier Universitaire, AmiensCompletedChild | Diagnosis | NIRS | Testicular Torsion | Diagnostic TestFrance
-
CHU de Quebec-Universite LavalOttawa Hospital Research Institute; Canadian Critical Care Trials Group; Canadian...RecruitingBrain Injuries | Anemia | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intensive Care Neurological Disorder | Near-Infrared SpectroscopyCanada
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
University of Wisconsin, MadisonCompletedAcute Kidney Injury | Premature InfantUnited States
-
Medical University of ViennaMunicipal Ambulance Service, Vienna, AustriaUnknownCardiac ArrestAustria
-
IWK Health CentreCompletedIntracranial HemorrhageCanada
-
Boston Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingNeonatal Encephalopathy | Hypoxic Ischemic Brain InjuryUnited States
-
University of UtahIntermountain Health Care, Inc.CompletedNecrotizing Enterocolitis | Congenital Heart Disease | Patent Ductus Arteriosus | Infant, PrematureUnited States