NIRS Guidance Trail in Children's Heart Surgery

Heart Defects, Congenital Clinical Trial

— NIRS  

Official title:

Randomized Trial of Near-infrared Spectroscopy to Guide Intraoperative and Intensive Care Management in Children's Heart Surgery Requiring Cardiopulmonary Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02157597
• Other study ID #: 2011-1677
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2012
• Last updated: August 4, 2015
• Start date: November 2011
• Est. completion date: October 2016

Study information

• Verified date: August 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Jayant Nick Pratap
• Phone: 513-497-5948
• Email: jayant.pratap[@]cchmc.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Other:
• NIRS based management
Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair Deepen anesthesia with volatile or intravenous agent. Consider Extra-Corporeal Membrane Oxygenation (ECMO).
• Control
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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	American Society of Anesthesiologists, International Anesthesia Research Society (IARS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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],duration of pre-CPB and post-CPB, and NIRS complications [e.g. pressure injury]) recorded by a study coordinator.	participants will be followed for the duration of surgery and the CICU stay, an expected average of 3 weeks.	No
Secondary	Associated outcomes to heart surgery	Secondary outcomes include cardiac failure [need for ECMO], duration of pre-CPB and post-CPB, and NIRS complications [e.g. pressure injury]) recorded by a study coordinator.	participants will be followed for the duration of surgery and the CICU stay, an expected average of 3 weeks.	No