Anesthesia ComplicationNCT03136952
Cerebral Oxygenation, Different Measurement Points and Their Correlation in Pediatric Population
An observational study of Anesthesia Complication and Surgical Blood Loss, run by Göteborg University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Anesthesia Complication, Surgical Blood Loss
- What is being tested?
- NIRS frontal and occipital
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Children under one yrs old which shall undergo cleft lip \& palate surgery during general anesthesia.
Who may be able to join
- All children who will undergo cleft lip \& palate surgery during general anesthesia.
- Exclusion Criteria: Braintumor, neuropsychiatric diseases or ASA 3 classification.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska academy, University of Gothenburg
Gothenburg, Box 457 405 30 Göteborg
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia Complication, Surgical Blood Loss
- Being tested
- NIRS frontal and occipital
- Keywords
- NIRS, Monitoring, Pediatric
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS frontal and occipitalDevice
NIRS frontal and occipital on pediatric population during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Pediatric children under 1 yrs old | Observation study of two measurement points of cerebral oxygenation Receives: Device: NIRS frontal and occipital |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS correlation
NIRS correlation between frontal and occipital measurement points
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start28 Apr 2017
- Primary completion5 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pether Jildenstal, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136952
- Sponsor's protocol ID
- Dnr 106-17.
- Status last verified
- Dec 2018
- First submitted
- 28 Apr 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03136952
- Acronym / sponsor ID
- Dnr 106-17.
- Conditions
- Anesthesia Complication, Surgical Blood Loss
- Keywords
- NIRS, Monitoring, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric children under 1 yrs old | – | Device: NIRS frontal and occipitalObservation study of two measurement points of cerebral oxygenation |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under one yrs old which shall undergo cleft lip \& palate surgery during general anesthesia.
Key inclusion criteria (3 listed)
- All children who will undergo cleft lip \& palate surgery during general anesthesia.
- Exclusion Criteria: Braintumor, neuropsychiatric diseases or ASA 3 classification.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NIRS frontal and occipitalNIRS frontal and occipital on pediatric population during general anesthesia | Device | Pediatric children under 1 yrs old |
Primary outcome
NIRS correlation
Time frame: 1 yr
NIRS correlation between frontal and occipital measurement points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- 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?
An observational study of Anesthesia Complication and Surgical Blood Loss, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 0 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 11 Dec 2018. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NIRS correlation (time frame: 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2018.