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Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation (DEX-CO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01001533
First received: October 23, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.


Condition
Cardiac Output
Sedation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Assess the Ability of Non-invasive Bio-impedance Cardiac Monitoring to Detect and Trend Hemodynamic Variables During Dexmedetomidine (DEX) Sedation in Children for Radiology Procedures

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • The primary aim is to ascertain if a decrease in heart rate (HR) with intravenous (IV) DEX is associated with a change in trend of cardiac output (CO) as measured by the ICON device. [ Time Frame: pre-, during, and post sedation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the cardiac parameters provided by the ICON device during changes in blood pressure. [ Time Frame: pre-, during and post sedation ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children sedated by DEX
All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will have their vital signs and ICON measurements recorded continuously pre-sedation, during sedation and through recovery until discharge.

Criteria

Inclusion Criteria:

  • All pediatric patients (1 month to 18 years of age)
  • Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
  • Scan procedure

Exclusion Criteria:

  • Pacemakers and Vagus Nerve Stimulator
  • Mitral or Aorta Valve Dysfunction
  • Dextrocardia
  • Second or Third degree heart block
  • Current diagnosis of Cardiac, Pulmonary, Hepatic or Renal Failure
  • Current diagnosis of pulmonary masses/tumor/pleural effusions/pneumonia/edema
  • Pericardial effusion
  • Concomitant use of hypertension medications including ACE inhibitors, beta receptor and calcium channel blockers.
  • Large Implanted Metallic Devices (including orthodontic braces, spine rods, plates and screws)
  • Allergy to device electrodes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001533

Locations
United States, Massachusetts
Children Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Jackson Wong, MD Children Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jackson Wong MD, Children Hospital Boston
ClinicalTrials.gov Identifier: NCT01001533     History of Changes
Other Study ID Numbers: 09-03-0130
Study First Received: October 23, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Electrical Cardiometry
Dexmedetomidine
ICON
bio-impedance
cardiac monitor

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014