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

How Cerebral Oxygenation Correlates, Measured at Various Cranial Points, Frontally and Occipital in Children Under 1 Years Old, During General Anesthesia and Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgical Blood Loss; Anesthesia Complication
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, Box 457 405 30 Göteborg
    • Sahlgrenska academy, University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under one yrs old which shall undergo cleft lip & palate surgery during general anesthesia.

Description

Inclusion Criteria:

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

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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIRS correlation	NIRS correlation between frontal and occipital measurement points	1 yr

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Monitoring; Pediatric; NIRS
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: Dnr 106-17.

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: No