NIRS Guidance Trail in Children's Heart Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | October 2016 |
| Contact: | Jayant Nick Pratap |
| Email: | jayant.pratap@cchmc.org |
| Phone: | 513-497-5948 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-497-5948
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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