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

NCT03136952 | Completed

• 1 other identifier: Dnr 106-17.
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Complication; Surgical Blood Loss

Keywords

NIRS; Monitoring; Pediatric

Outcome Measures

Primary Outcomes (1)

• NIRS correlation

  NIRS correlation between frontal and occipital measurement points

  1 yr

Study Arms (1)

Pediatric children under 1 yrs old

Observation study of two measurement points of cerebral oxygenation

Device: NIRS frontal and occipital

Interventions

NIRS frontal and occipital DEVICE

NIRS frontal and occipital on pediatric population during general anesthesia

Pediatric children under 1 yrs old

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska academy, University of Gothenburg

Gothenburg, Box 457 405 30 Göteborg, Sweden

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.professor

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: April 28, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 30, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)