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Cerebral Oxygenation, Different Measurement Points and Their Correlation in Pediatric Population

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ClinicalTrials.gov Identifier: NCT03136952
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pether Jildenstal, Göteborg University

Brief Summary:

Children who undergo surgery routinely for surgery that risk high levels of circulatory changes (eg heart surgery) is currently used routinely monitoring as regional oxygenation technology of the brain (NIRS). Near infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation, indirect autoregulation of brain. We know that reduced oxygenation of the brain can occur with severe immediate blood loss. We in the research group has been able to note that in children who undergo surgery for cranioplasty interventions <1 year old, when they have ongoing excessive bleeding, decreases oxygenation in the brain and sometimes sharply before we can replace the loss of blood, even the blood pressure can be adequately maintained. Perioperative hypovolemia is a risk factor upset autoregulation of brain. Respect of which the mean arterial pressure (MAP) required to maintain intact autoregulation during general anesthesia still lacks a scientific consensus.

By illuminating the skin and underlying tissue with infrared light in the spectra of 700 to 1100nm, it is possible to measure regional oxygen saturation in various tissues. At cerebral measuring sensor is placed frontally, just below the hairline. INVOS then returns the absolute values of cerebral oxygen saturation frontally in the area where the sensor is placed.

A frontal placement may in some cases be impractical / impossible and thus limits the ability to monitor the brains of children with different types of surgery or body positions. At certain cranioplastic intervention surgery a frontal placement is not always possible, partly because of surgical technic reasons, but also that the child may have to lie prone during surgery. An alternative placement of INVOS sensor could mean greater opportunities to monitor cerebral oxygen saturation and thus increase patient safety within the mentioned categories of patients. An occipital location is practically possible in many cases. The purpose of this study is to investigate whether a occipital located sensor can measure cerebral oxygen saturation in a reliable manner.


Condition or disease Intervention/treatment
Anesthesia Complication Surgical Blood Loss Device: NIRS frontal and occipital

Detailed Description:

We want to study patients undergoing cleft lip and palate plastic surgery at Sahlgrenska University Hospital. This population has been chosen because it is an age group that is homogeneous and suits our aim "two different measuring points (frontal and occipitalt) of sensors for regional cerebral oxygenation in children under 1 yrs old, during general anesthesia and surgery. We will use a INVOS 5100 (the latest version of INVOS). A sensor will be applied, frontally and occipital on the head.

Patients will be enrolled consecutively when they have been planned for surgery, at Salhgrenska University Hospital.

Perioperative data will be registered in 5-minute intervals from frontally and occipital measurements. The measurements begin before the patient is anesthetized and ends when the patient is extubated.

All monitoring data during the general anesthesia will be obtained and documented in a data sheet.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Cerebral Oxygenation Correlates, Measured at Various Cranial Points, Frontally and Occipital in Children Under 1 Years Old, During General Anesthesia and Surgery
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 30, 2018

Group/Cohort Intervention/treatment
Pediatric children under 1 yrs old
Observation study of two measurement points of cerebral oxygenation
Device: NIRS frontal and occipital
NIRS frontal and occipital on pediatric population during general anesthesia




Primary Outcome Measures :
  1. NIRS correlation [ Time Frame: 1 yr ]
    NIRS correlation between frontal and occipital measurement points



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Ages Eligible for Study:   3 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under one yrs old which shall undergo cleft lip & palate surgery during general anesthesia.
Criteria

Inclusion Criteria:

- All children who will undergo cleft lip & palate surgery during general anesthesia.

Exclusion Criteria: Braintumor, neuropsychiatric diseases or ASA 3 classification.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136952


Locations
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Sweden
Sahlgrenska academy, University of Gothenburg
Gothenburg, Sweden, Box 457 405 30 Göteborg
Sponsors and Collaborators
Göteborg University
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Responsible Party: Pether Jildenstal, Ass.professor, Göteborg University
ClinicalTrials.gov Identifier: NCT03136952    
Other Study ID Numbers: Dnr 106-17.
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pether Jildenstal, Göteborg University:
NIRS
Monitoring
Pediatric
Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications