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Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01287572
Collaborator
(none)
80
Enrollment
1
Location
18
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2.

The rise in CO2 levels is not well described and unpredicted. In this study the investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a device recently approved for clinical use. The hypothesis is ventilation of patients undergoing conscious sedation is compromised and CO2 levels might rise significantly to levels that potentially can effect hemodynamics.

In order to avoid hemodynamic changes proper and routine monitoring is recommended.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit
    Study Start Date :
    Feb 1, 2011
    Anticipated Primary Completion Date :
    Feb 1, 2012
    Anticipated Study Completion Date :
    Aug 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Conscious sedation group

    Pediatric patients 0 to 18 years requiring conscious sedation for procedures done in the pediatric ICU excluding burned patients or patients with severe eczema or other skin disease.

    Outcome Measures

    Primary Outcome Measures

    1. TcCO2 level [One year]

      Transcutaneous measurement of patients undergoing conscious sedation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit

    • patients requiring minor surgical procedures (e.g. bronchoscopy, central venous line placement, lumbar puncture, intracranial pressure monitoring device insertion)

    Exclusion Criteria:

    • skin disease

    • burns to thorax

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    • Principal Investigator: Yakov Sivan, MD, Tel-Aviv Sourasky Medical Center
    • Study Director: Efraim Sadot, MD, Tel-Aviv Sourasky Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01287572
    Other Study ID Numbers:
    • TASMC-10-YS-319-CTIL
    First Posted:
    Feb 1, 2011
    Last Update Posted:
    Feb 1, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    TcCO2
    sedation
    procedure
    PICU

    Study Results

    No Results Posted as of Feb 1, 2011