Heart Defects, CongenitalNIRSNCT02157597
NIRS Guidance Trail in Children's Heart Surgery
A study testing NIRS based management in people with Heart Defects, Congenital, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- NIRS based management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2016
- Phase
- Interventional
- 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 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- undergoing elective or emergency heart surgery
- under 6 months of age
- operation requiring cardiopulmonary bypass
- complex operation, defined as RACH-1 score 3 to 6 inclusive
Who cannot join
- weight less than 2 kg
- prematurity defined as less than or equal to 36 weeks post-concepional age at tme of operation
- preoperative renal failure defined as serum creatinine greater than 132 mmol/l
- major non-cardiac congenital anomalies or preoperative non-cardiac disease
- operation or any of its components not classified in the RACHS-1 system
- receiving preoperative mechanical circulatory support
- presence of known intracranial hematomas or cerebral arteriovenous malformations
- reoperation if previously enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Randomized Trial of Near-infrared Spectroscopy to Guide Intraoperative and Intensive Care Management in Children's Heart Surgery Requiring Cardiopulmonary Bypass
Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA).
The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.
Read the detailed description
The NIRS monitor will record information from the patient until he/she has been in the CICU for about 24 hours. The monitoring consists of small sticky pads placed on the child's forehead and trunk. These work like the pulse oximeter (oxygen monitor) that has been used for for the child already, but have a more sensitive detector.
NIRS data will be recorded in the operating room and in the CICU for all babies in the study. The NIRS values can be seen by the surgical and anesthesia teams in the operating room for all babies in the study. Once the patient is in the CICU, the NIRS values will be visible to the CICU team only if he/she is assigned to the intervention group. If he/she is assigned to the control group the NIRS values will not be visible to the CICU team. Currently, use of the NIRS monitor is not standard care in the CICU.
For half of the children in the study (intervention group) the team will follow a carefully designed plan on how to react to any changes seen. For the other half of the children (control group) the team will respond to any changes seen according to their standard practice. For the control group NIRS monitoring will occur in the operating room but not in the CICU. By using two groups, the investigators can compare the NIRS recordings. In this way the investigators will find out if blood supply to the tissues is altered.
No standard monitoring or treatments will be withheld from the patient.
Some extra urine tests will be taken in the 24 hours following surgery. They will be taken from the catheter inserted into the patient's bladder, as is standard for all heart surgery. No genetic tests will be done.
The patient will have usual medical care following the 24 hours of the study. The investigators will use the hospital's electronic notes to collect further information. This will include medications, routine labs and vital signs. The investigators may also call the family 60 days after surgery with a few simple questions about the patient's current state of health.
- Conditions
- Heart Defects, Congenital
- Being tested
- NIRS based management, Control
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS based managementOther
- Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair
- Deepen anesthesia with volatile or intravenous agent.
- Consider Extra-Corporeal Membrane Oxygenation (ECMO).
ControlOther
During the Control Arm, the medical team completes all tasks as clinically necessary and in the best medical interest of the patient, without any input from the study procedures
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | The control patients will have open display of the NIRS monitor in the OR, but recording without display in the CICU, along with a request to the surgical and intensive teams to react to the data in their usual way. The disparity between the OR and CICU reflect the current opinions of the clinicians in these different environments regarding the necessity of NIRS monitoring within their sphere of practice.
In this way, continuous recording of cerebral and somatic oximetry will be made in all patients. However for control patients the monitor display will be switched off in the CICU using a pre-programmed research mode, which permits both ongoing recording and also the display of technical error messages (such as inadvertent disconnections or probe displacement). Receives: Other: Control |
| NIRS based management | Experimental | The trial interventions of NIRS based management consists of provision to the cardiac surgical and intensive care teams of a protocol to guide their interpretation of cerebral and somatic NIRS monitoring and interventions to try in the event of monitored desaturation during the pre- and post-bypass periods (when the circulation is perfused by the beating of the native heart). The investigators believe that there is insufficient data to inform an evidence-based protocol for the bypass phase of surgery, particularly regarding the interpretation of NIRS data under conditions of hypothermia. Receives: Other: NIRS based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative time that NIRS is below threshold (from continuous electronic recording of NIRS data)
The investigators will assess effects of NIRS guidance in two ways. The primary outcome measure is the cumulative time (AUC) that rScO2 is below threshold (from continuous electronic recording of NIRS data). rScO2 will be taken as the mean of left and right forehead sensor readings. AUC will be calculated before and after CPB in the OR and during the first 24 hours postop in the CICU, and summed. Initial analyses of primary outcome to compare treatment groups will be undertaken on an intention-to-treat basis.
Measured: participants will be followed for the duration of surgery and during the first 24 hours postop in the CICU, an expected average of 35 hours.
Secondary outcomes (1)
Associated outcomes to heart surgery
Secondary outcomes include number and types of interventions, number and type of adverse events in the OR before and after CPB and in the CICU (e.g. cardiac arrest [need for chest compressions, defibrillation,ECMO],duration of pre-CPB and post-CPB, and NIRS complications [e.g. pressure injury]) recorded by a study coordinator.
Measured: participants will be followed for the duration of surgery and the CICU stay, an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Anesthesiologists, International Anesthesia Research Society (IARS)
- Responsible party
- Sponsor
- Investigators
- Jayant Nick Pratap, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157597
- Sponsor's protocol ID
- 2011-1677
- Acronym
- NIRS
- Status last verified
- May 2016
- First submitted
- 15 Nov 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Near-infrared Spectroscopy to Guide Intraoperative and Intensive Care Management in Children's Heart Surgery Requiring Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02157597
- Acronym / sponsor ID
- NIRS / 2011-1677
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- American Society of Anesthesiologists, International Anesthesia Research Society (IARS)
- Study start
- Nov 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jun 2014 (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.
Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA).
The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.
Detailed description
The NIRS monitor will record information from the patient until he/she has been in the CICU for about 24 hours. The monitoring consists of small sticky pads placed on the child's forehead and trunk. These work like the pulse oximeter (oxygen monitor) that has been used for for the child already, but have a more sensitive detector.
NIRS data will be recorded in the operating room and in the CICU for all babies in the study. The NIRS values can be seen by the surgical and anesthesia teams in the operating room for all babies in the study. Once the patient is in the CICU, the NIRS values will be visible to the CICU team only if he/she is assigned to the intervention group. If he/she is assigned to the control group the NIRS values will not be visible to the CICU team. Currently, use of the NIRS monitor is not standard care in the CICU.
For half of the children in the study (intervention group) the team will follow a carefully designed plan on how to react to any changes seen. For the other half of the children (control group) the team will respond to any changes seen according to their standard practice. For the control group NIRS monitoring will occur in the operating room but not in the CICU. By using two groups, the investigators can compare the NIRS recordings. In this way the investigators will find out if blood supply to the tissues is altered.
No standard monitoring or treatments will be withheld from the patient.
Some extra urine tests will be taken in the 24 hours following surgery. They will be taken from the catheter inserted into the patient's bladder, as is standard for all heart surgery. No genetic tests will be done.
The patient will have usual medical care following the 24 hours of the study. The investigators will use the hospital's electronic notes to collect further information. This will include medications, routine labs and vital signs. The investigators may also call the family 60 days after surgery with a few simple questions about the patient's current state of health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: ControlThe control patients will have open display of the NIRS monitor in the OR, but recording without display in the CICU, along with a request to the surgical and intensive teams to react to the data in their usual way. The disparity between the OR and CICU reflect the current opinions of the clinicians in these different environments regarding the necessity of NIRS monitoring within their sphere of practice. In this way, continuous recording of cerebral and somatic oximetry will be made in all patients. However for control patients the monitor display will be switched off in the CICU using a pre-programmed research mode, which permits both ongoing recording and also the display of technical error messages (such as inadvertent disconnections or probe displacement). |
| NIRS based management | Experimental | Other: NIRS based managementThe trial interventions of NIRS based management consists of provision to the cardiac surgical and intensive care teams of a protocol to guide their interpretation of cerebral and somatic NIRS monitoring and interventions to try in the event of monitored desaturation during the pre- and post-bypass periods (when the circulation is perfused by the beating of the native heart). The investigators believe that there is insufficient data to inform an evidence-based protocol for the bypass phase of surgery, particularly regarding the interpretation of NIRS data under conditions of hypothermia. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- undergoing elective or emergency heart surgery
- under 6 months of age
- operation requiring cardiopulmonary bypass
- complex operation, defined as RACH-1 score 3 to 6 inclusive
Key exclusion criteria (8 listed)
- weight less than 2 kg
- prematurity defined as less than or equal to 36 weeks post-concepional age at tme of operation
- preoperative renal failure defined as serum creatinine greater than 132 mmol/l
- major non-cardiac congenital anomalies or preoperative non-cardiac disease
- operation or any of its components not classified in the RACHS-1 system
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 based management1. Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair 2. Deepen anesthesia with volatile or intravenous agent. 3. Consider Extra-Corporeal Membrane Oxygenation (ECMO). | Other | NIRS based management |
| ControlDuring the Control Arm, the medical team completes all tasks as clinically necessary and in the best medical interest of the patient, without any input from the study procedures | Other | Control Arm |
Primary outcome
Cumulative time that NIRS is below threshold (from continuous electronic recording of NIRS data)
Time frame: participants will be followed for the duration of surgery and during the first 24 hours postop in the CICU, an expected average of 35 hours.
The investigators will assess effects of NIRS guidance in two ways. The primary outcome measure is the cumulative time (AUC) that rScO2 is below threshold (from continuous electronic recording of NIRS data). rScO2 will be taken as the mean of left and right forehead sensor readings. AUC will be calculated before and after CPB in the OR and during the first 24 hours postop in the CICU, and summed. Initial analyses of primary outcome to compare treatment groups will be undertaken on an intention-to-treat basis.
1 secondary outcome
Associated outcomes to heart surgery
Time frame: participants will be followed for the duration of surgery and the CICU stay, an expected average of 3 weeks.
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 12 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jayant Nick Pratap principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS based management in people with Heart Defects, Congenital, run by Children's Hospital Medical Center, Cincinnati 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 4 inclusion and 8 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 12 May 2016. 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?
Cumulative time that NIRS is below threshold (from continuous electronic recording of NIRS data) (time frame: participants will be followed for the duration of surgery and during the first 24 hours postop in the CICU, an expected average of 35 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 12 May 2016.