Pediatric Intensive Care UnitNCT01282099
A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)
An observational study of Pediatric Intensive Care Unit, run by Akron Children's Hospital at 1 site in United States.
Trial summary
While near infrared spectroscopy is an exciting technology, scientific rigor is required in order to optimize its appropriate use in the clinical arena. This study will explore the feasibility and clinical applicability of data obtained from the NIRS device. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Intensive Care Unit
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2013
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: neonates to 16 years of age requiring stay in the PICU postoperative congenital heart disease patients non-cardiac patients
Who may be able to join
- neonates to 16 year olds
- requiring stay in the PICU greater than 24 hours
Who cannot join
- anticipated PICU stay less than 24 hours
- children with ALLOW NATURAL DEATH orders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Canary in the PICU? A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)
While near infrared spectroscopy is an exciting technology, scientific rigor is required in order to optimize its appropriate use in the clinical arena. This study will explore the feasibility and clinical applicability of data obtained from the NIRS device. The ability to noninvasively monitor peripheral perfusion remains an area of intense research. The most widely used method is pulse oximetry. The international mandate of its use in operating rooms in the early 1990s after the publication of the Harvard minimum standards for monitoring speaks to its unquestionable utility. Its pervasive application notwithstanding, pulse oximetry merely provides a calibrated ratio of arterial and venous hemoglobin saturation. While this data is valuable, time-tested, and even may hold the promise of accurately noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of vulnerable, yet viable tissue beds -- are beyond the predictive values of currently available devices.
- Conditions
- Pediatric Intensive Care Unit
- Keywords
- all children entering the PICU eligible for enrollment, age range: neonate to 16 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac patients | Postoperative congenital heart disease patients requiring stay in the PICU | |
| non-cardiac patients | non-cardiac patients requiring stay in the PICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters
Upon arrival to PICU, 1 lead will be place on the forehead to monitor cerebral regional saturation (CrSO2)and 1 lead will be placed on the flank to measure somatic regional saturation (SrSO2).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pediatric Intensive Care UnitStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Forbes, MD, FAAP, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282099
- Sponsor's protocol ID
- 100603
- Status last verified
- Jun 2014
- First submitted
- 21 Jan 2011
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lima A, Bakker J. Noninvasive monitoring of peripheral perfusion. Intensive Care Med. 2005 Oct;31(10):1316-26. doi: 10.1007/s00134-005-2790-2. Epub 2005 Sep 17.
PubMed 16170543Kelleher JF. Pulse oximetry. J Clin Monit. 1989 Jan;5(1):37-62. doi: 10.1007/BF01618369.
PubMed 2647912Webster JG 1997 Design of Pulse Oximeters (Bristol: Institute of Physics Publishing)
Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
PubMed 12072670Armonda RA, McGee B, Veznadaraglu E, Rosenwasser RH. Near-infrared spectroscopy (NIRS) measurements of cerebral oximetry in the neurovascular ICU. Crit Care Med 1999; 27:173
Kohn, Linda T, Corrigan, J, Donaldson, Molla S. To err is human: building a safer health system. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Vol. 627, Nov.1999
Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices. Crit Care Med. 1995 Oct;23(10):1756-63. doi: 10.1097/00003246-199510000-00022.
PubMed 7587243Prough DS, Pollard V. Cerebral near-infrared spectroscopy: ready for prime time? Crit Care Med. 1995 Oct;23(10):1624-6. doi: 10.1097/00003246-199510000-00004. No abstract available.
PubMed 7587225Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):57-63. doi: 10.1007/s11606-007-0275-4.
PubMed 18095046Mullner M, Sterz F, Binder M, Hirschl MM, Janata K, Laggner AN. Near infrared spectroscopy during and after cardiac arrest--preliminary results. Clin Intensive Care. 1995;6(3):107-11.
PubMed 10150558Schwarz G, Litscher G, Kleinert R, Jobstmann R. Cerebral oximetry in dead subjects. J Neurosurg Anesthesiol. 1996 Jul;8(3):189-93. doi: 10.1097/00008506-199607000-00001.
PubMed 8803829Tobias JD. Cerebral oximetry monitoring with near infrared spectroscopy detects alterations in oxygenation before pulse oximetry. J Intensive Care Med. 2008 Nov-Dec;23(6):384-8. doi: 10.1177/0885066608324380.
PubMed 18794168Tobias JD. Cerebral oximetry monitoring provides early warning of hypercyanotic spells in an infant with tetralogy of Fallot. J Intensive Care Med. 2007 Mar-Apr;22(2):118-20. doi: 10.1177/0885066606297966.
PubMed 17456731Lee TS, Hines GL, Feuerman M. Significant correlation between cerebral oximetry and carotid stump pressure during carotid endarterectomy. Ann Vasc Surg. 2008 Jan;22(1):58-62. doi: 10.1016/j.avsg.2007.07.022. Epub 2007 Nov 26.
PubMed 18023554
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Canary in the PICU? A Critical Appraisal of the Role of Near Infrared Spectroscopy (NIRS) in the Pediatric Intensive Care Unit (PICU)
- ClinicalTrials.gov ID
- NCT01282099
- Acronym / sponsor ID
- 100603
- Conditions
- Pediatric Intensive Care Unit
- Keywords
- all children entering the PICU eligible for enrollment, age range: neonate to 16 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jan 2011 (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.
While near infrared spectroscopy is an exciting technology, scientific rigor is required in order to optimize its appropriate use in the clinical arena. This study will explore the feasibility and clinical applicability of data obtained from the NIRS device. The ability to noninvasively monitor peripheral perfusion remains an area of intense research. The most widely used method is pulse oximetry. The international mandate of its use in operating rooms in the early 1990s after the publication of the Harvard minimum standards for monitoring speaks to its unquestionable utility. Its pervasive application notwithstanding, pulse oximetry merely provides a calibrated ratio of arterial and venous hemoglobin saturation. While this data is valuable, time-tested, and even may hold the promise of accurately noninvasively trending cardiac output, cellular dysmetabolism -- hallmarks of vulnerable, yet viable tissue beds -- are beyond the predictive values of currently available devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac patients | – | –Postoperative congenital heart disease patients requiring stay in the PICU |
| non-cardiac patients | – | –non-cardiac patients requiring stay in the PICU |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- neonates to 16 years of age requiring stay in the PICU postoperative congenital heart disease patients non-cardiac patients
Key inclusion criteria (2 listed)
- neonates to 16 year olds
- requiring stay in the PICU greater than 24 hours
Key exclusion criteria (2 listed)
- anticipated PICU stay less than 24 hours
- children with ALLOW NATURAL DEATH orders
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
Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters
Time frame: 48 hours
Upon arrival to PICU, 1 lead will be place on the forehead to monitor cerebral regional saturation (CrSO2)and 1 lead will be placed on the flank to measure somatic regional saturation (SrSO2).
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 26 Jun 2014.
- Background: PubMed 16170543Lima A, Bakker J. Noninvasive monitoring of peripheral perfusion. Intensive Care Med. 2005 Oct;31(10):1316-26. doi: 10.1007/s00134-005-2790-2. Epub 2005 Sep 17.
- Background: PubMed 2647912Kelleher JF. Pulse oximetry. J Clin Monit. 1989 Jan;5(1):37-62. doi: 10.1007/BF01618369.
- BackgroundWebster JG 1997 Design of Pulse Oximeters (Bristol: Institute of Physics Publishing)
- Background: PubMed 12072670Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
- BackgroundArmonda RA, McGee B, Veznadaraglu E, Rosenwasser RH. Near-infrared spectroscopy (NIRS) measurements of cerebral oximetry in the neurovascular ICU. Crit Care Med 1999; 27:173
- BackgroundKohn, Linda T, Corrigan, J, Donaldson, Molla S. To err is human: building a safer health system. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Vol. 627, Nov.1999
- Background: PubMed 7587243Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices. Crit Care Med. 1995 Oct;23(10):1756-63. doi: 10.1097/00003246-199510000-00022.
- Background: PubMed 7587225Prough DS, Pollard V. Cerebral near-infrared spectroscopy: ready for prime time? Crit Care Med. 1995 Oct;23(10):1624-6. doi: 10.1097/00003246-199510000-00004. No abstract available.
- Background: PubMed 18095046Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):57-63. doi: 10.1007/s11606-007-0275-4.
- Background: PubMed 10150558Mullner M, Sterz F, Binder M, Hirschl MM, Janata K, Laggner AN. Near infrared spectroscopy during and after cardiac arrest--preliminary results. Clin Intensive Care. 1995;6(3):107-11.
- Background: PubMed 8803829Schwarz G, Litscher G, Kleinert R, Jobstmann R. Cerebral oximetry in dead subjects. J Neurosurg Anesthesiol. 1996 Jul;8(3):189-93. doi: 10.1097/00008506-199607000-00001.
- Background: PubMed 18794168Tobias JD. Cerebral oximetry monitoring with near infrared spectroscopy detects alterations in oxygenation before pulse oximetry. J Intensive Care Med. 2008 Nov-Dec;23(6):384-8. doi: 10.1177/0885066608324380.
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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.
Michael L Forbes, MD, FAAP principal investigator
Akron Children's Hospital
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 Pediatric Intensive Care Unit, run by Akron Children's Hospital 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 2 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 26 Jun 2014. 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?
Comparison of data obtained using Near Infrared Spectroscopy (NIRS) versus traditional Pediatric Intensive Care Unit (PICU) clinical parameters (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282099, which also lists 14 linked publications.
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 26 Jun 2014.