AnesthesiaNCT02442141
Peri-operative NIRS Monitoring In Infants
An observational study of Anesthesia, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Anesthesia
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2015to 27 Sep 2016
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Children will be identified from the operating room schedules or, for emergency cases the coordinating anesthetist will contact the study team.
Who may be able to join
- Less than 6 months
- Scheduled for intubation/anesthesia for clinical purposes for a surgical procedure in the Children's Hospital of Philadelphia (CHOP) Main operating room that is expected to last longer than 30 minutes
Who cannot join
- Children where application of the NIRS would be impractical: for example surgery on the head or neck.
- Children scheduled for cardiac surgery
- Children with known major cardiovascular shunting
- Children with known or suspected neurological abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cerebral Near-infrared Spectroscopy Monitoring in Infants During the Peri-operative Period: a Prospective Observational Cohort Study
The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.
Read the detailed description
Pre-operatively medical history will be collected along with baseline physiological data (Blood pressure, heart rate, date of birth, date of surgery, weight, gestational age at birth, gender, medical conditions, and medications). Given the importance of reliable blood pressure measurement- during the study, strict guidelines regarding proper blood pressure cuff placement and choice of cuff size will be followed. An upper extremity and the cuff index lines will be used to make sure that the cuff is appropriately sized. NIRS sensors will be applied pre-operatively in the operating room prior to induction of anesthesia. All NIRS values will be collected as blind values so as to not influence anesthetic management or clinical decisions.
Intra-operatively the NIRS values will be blindly recorded, physiological data and details of the anesthesia (the conduct of all clinical monitoring, including blood pressure measurements and anesthesia will not be affected in any way by this study). No additional blood pressure or other measurements will be made.
One week later the hospital record (for those infants still hospitalized) will be reviewed for evidence of new changes in neurological status (specifically seizures or other generalized or focal neurological deficits noted by the clinical team in the record and physical exam). For infants discharged home prior to one week after surgery, a phone call will be made to inquire about the occurrence of any events that required medical attention or treatment.
- Conditions
- Anesthesia
- Keywords
- Near-Infrared Spectroscopy, Cerebral, Infants, Anesthesia, Neurodevelopmental
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and range of cerebral deoxygenation during anesthesia in infants
This data will be obtained by using an FDA-approved NIRS monitor. This device measures regional tissue hemoglobin saturation using combinations of spatially resolved near-infrared spectroscopy and modified Beer-Lambert law approaches, along with measure changes in tissue hemoglobin concentrations; in combination, these measurements allow changes in oxy- and deoxyhemoglobin concentrations in the tissue to be calculated. Data will be recorded prior to induction of anesthesia and throughout the procedure until the infant begins to wake or 30 after arrival to the unit, whichever occurs first.
Measured: Duration of surgery (Up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start28 Apr 2015
- Primary completion31 May 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis X McGowan, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442141
- Sponsor's protocol ID
- 14-011407
- Status last verified
- May 2018
- First submitted
- 5 May 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Near-infrared Spectroscopy Monitoring in Infants During the Peri-operative Period: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02442141
- Acronym / sponsor ID
- 14-011407
- Conditions
- Anesthesia
- Keywords
- Near-Infrared Spectroscopy, Cerebral, Infants, Anesthesia, Neurodevelopmental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.
Detailed description
Pre-operatively medical history will be collected along with baseline physiological data (Blood pressure, heart rate, date of birth, date of surgery, weight, gestational age at birth, gender, medical conditions, and medications). Given the importance of reliable blood pressure measurement- during the study, strict guidelines regarding proper blood pressure cuff placement and choice of cuff size will be followed. An upper extremity and the cuff index lines will be used to make sure that the cuff is appropriately sized. NIRS sensors will be applied pre-operatively in the operating room prior to induction of anesthesia. All NIRS values will be collected as blind values so as to not influence anesthetic management or clinical decisions.
Intra-operatively the NIRS values will be blindly recorded, physiological data and details of the anesthesia (the conduct of all clinical monitoring, including blood pressure measurements and anesthesia will not be affected in any way by this study). No additional blood pressure or other measurements will be made.
One week later the hospital record (for those infants still hospitalized) will be reviewed for evidence of new changes in neurological status (specifically seizures or other generalized or focal neurological deficits noted by the clinical team in the record and physical exam). For infants discharged home prior to one week after surgery, a phone call will be made to inquire about the occurrence of any events that required medical attention or treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children will be identified from the operating room schedules or, for emergency cases the coordinating anesthetist will contact the study team.
Key inclusion criteria (2 listed)
- Less than 6 months
- Scheduled for intubation/anesthesia for clinical purposes for a surgical procedure in the Children's Hospital of Philadelphia (CHOP) Main operating room that is expected to last longer than 30 minutes
Key exclusion criteria (4 listed)
- Children where application of the NIRS would be impractical: for example surgery on the head or neck.
- Children scheduled for cardiac surgery
- Children with known major cardiovascular shunting
- Children with known or suspected neurological abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence and range of cerebral deoxygenation during anesthesia in infants
Time frame: Duration of surgery (Up to 6 hours)
This data will be obtained by using an FDA-approved NIRS monitor. This device measures regional tissue hemoglobin saturation using combinations of spatially resolved near-infrared spectroscopy and modified Beer-Lambert law approaches, along with measure changes in tissue hemoglobin concentrations; in combination, these measurements allow changes in oxy- and deoxyhemoglobin concentrations in the tissue to be calculated. Data will be recorded prior to induction of anesthesia and throughout the procedure until the infant begins to wake or 30 after arrival to the unit, whichever occurs first.
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 15 May 2018.
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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.
Francis X McGowan, MD principal investigator
Children's Hospital of Philadelphia
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, run by Children's Hospital of Philadelphia 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 2 inclusion and 4 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 15 May 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 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?
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?
The incidence and range of cerebral deoxygenation during anesthesia in infants (time frame: Duration of surgery (Up to 6 hours)). 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 15 May 2018.