NCT03650842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 6, 2019

Completed
Last Updated

December 6, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

August 27, 2018

Results QC Date

November 19, 2019

Last Update Submit

November 19, 2019

Conditions

Pyloric Stenosis

Outcome Measures

Primary Outcomes (4)

  • 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.

    At time of incision

  • 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.

    At the end of laparoscopy

  • 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.

    At time of incision

  • 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.

    At the end of laparoscopy

Study Arms (1)

Laparoscopic pyloromyotomy

EXPERIMENTAL

Infants undergoing laparoscopic pyloromyotomy.

Device: Near infrared spectroscopy (NIRS)

Interventions

Near infrared spectroscopy (NIRS)DEVICE

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.

Laparoscopic pyloromyotomy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Kamata M, Hakim M, Walia H, Tumin D, Tobias JD. Changes in cerebral and renal oxygenation during laparoscopic pyloromyotomy. J Clin Monit Comput. 2020 Aug;34(4):699-703. doi: 10.1007/s10877-019-00356-2. Epub 2019 Jul 19.

    PMID: 31325010DERIVED

MeSH Terms

Conditions

Pyloric Stenosis

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Gastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Joseph D. Tobias, MD
Organization
Nationwide Children's Hospital
Joseph.Tobias@nationwidechildrens.org
614-722-5817

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

July 7, 2017

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

December 6, 2019

Results First Posted

December 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)