NIRS Guidance Trail in Children's Heart Surgery

NCT02157597 | Completed DMC

• 1 other identifier: 2011-1677
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Associated outcomes to heart surgery

  participants will be followed for the duration of surgery and the CICU stay, an expected average of 3 weeks.

Study Arms (2)

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).

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.

Other: NIRS based management

Interventions

NIRS based management OTHER

1. 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).

NIRS based management

Control OTHER

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

Control Arm

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• American Society of Anesthesiologists: collaborator
• International Anesthesia Research Society (IARS): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jayant Nick Pratap

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: June 6, 2014
• Study Start: November 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)