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NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849120
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic

Tracking Information
First Submitted Date May 6, 2013
First Posted Date May 8, 2013
Last Update Posted Date April 14, 2017
Study Start Date May 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2013)
Venous lactate level [ Time Frame: 48 hours post surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2013)
Blood oxygen saturation level [ Time Frame: 48 hours after surgery ]
Oxygen saturation level will be measured by near-infrared spectroscopy (NIRS).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery
Official Title Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?
Brief Summary

Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is LCOS that is responsible for the majority of early postoperative deaths in this population of neonates and infants. Improved pediatric probes placed in peripheral locations using near infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations reflecting overall perfusion and oxygen balance in the tissues. Following parental or guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart disease will be enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be placed on the flank, lower extremities and the forehead. Continuous NIRS saturations will be monitored and stored for analysis. Point of care (POC) lactates will be obtained after admission to the intensive care unit (ICU) every 2 hours for the first 24 hours postoperatively, then once at 48 hours. The association between NIRS oxygen saturation and POC lactate values will be assessed using mixed linear models taking into account the repeated measures design. Exploratory analyses will be performed to assess whether NIRS oxygen saturation is associated with outcomes such as days in ICU, adverse events and mortality.

The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac output will allow better and earlier therapy for neonates and infants following cardiac surgery.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pediatric cardiac surgical patients that required cardiopulmonary bypass
Condition Congenital Heart Disease
Intervention Device: EQUANOX Advance 8004CB sensor
The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.
Study Groups/Cohorts Near-infrared spectroscopy (NIRS)
After cardiac surgery, all subjects will have EQUANOX Advance 8004CB sensors applied to peripheral sites (left and right calf and side of abdomen).
Intervention: Device: EQUANOX Advance 8004CB sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2015)
35
Original Estimated Enrollment
 (submitted: May 6, 2013)
30
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion:

  • pediatric patients 0-3 years of age
  • scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects

Exclusion:

  • weight < 2 kg or > 20 kg
  • greater than 3 years of age
  • thrombosed femoral arteries
  • prior fasciotomies
  • currently on extracorporeal membrane oxygenation (ECMO)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01849120
Other Study ID Numbers 12-003690
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William C. Oliver, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Nonin Medical, Inc
Investigators
Principal Investigator: William Oliver, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2017