Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation

NCT ID: NCT01001533

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Output Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jackson Wong

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jackson Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Children Hospital Boston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.

Reference Type DERIVED
PMID: 21965374 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-03-0130

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cardiac Resynchronisation Study
NCT01213537 COMPLETED
CRT-P or CRT-D in Dilated Cardiomyopathy
NCT04139460 NOT_YET_RECRUITING NA