Pyloric StenosisNCT03650842
Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
A study testing Near infrared spectroscopy (NIRS) in people with Pyloric Stenosis, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pyloric Stenosis
- What is being tested?
- Near infrared spectroscopy (NIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Pyloric Stenosis
- Being tested
- Near infrared spectroscopy (NIRS)
- Medical subject headings
- Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic pyloromyotomy | Experimental | Infants undergoing laparoscopic pyloromyotomy. Receives: Device: Near infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start7 Jul 2017
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pyloric StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650842
- Sponsor's protocol ID
- IRB16-00199
- Status last verified
- Nov 2019
- First submitted
- 27 Aug 2018
- Last updated
- 6 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31325010
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
- ClinicalTrials.gov ID
- NCT03650842
- Acronym / sponsor ID
- IRB16-00199
- Conditions
- Pyloric Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 6 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic pyloromyotomy | Experimental | Device: Near infrared spectroscopy (NIRS)Infants undergoing laparoscopic pyloromyotomy. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopy (NIRS)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. | Device | Laparoscopic pyloromyotomy |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31325010Kamata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared spectroscopy (NIRS) in people with Pyloric Stenosis, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Regional Oxygen Saturation (rSO2) (time frame: At time of incision). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.