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Early Recognition of Hypoxia in Pediatric Patient Sedation

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04622436
Collaborator
(none)
4
Enrollment
1
Location
6
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Early recognition of hypoxia through monitoring in sedation practices in pediatric patients

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    Apr 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Early recognition of hypoxia [during the procedure]

      The rapid recognition of hypoxia that may occur with the initiation of the procedure

    2. the changes in partial oxygen saturation [during the procedure]

      The rapid recognition of changes in partial oxygen saturation

    Secondary Outcome Measures

    1. Sedation score [during the procedure]

      Monitoring ramsey sedation scale. The minimum value is 1 and the maximum value is 6. Higher score means more sedatized.

    2. recovery time [immediately after the procedure]

      length of stay in the recovery room

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia
    Exclusion Criteria:

    • Patients over the age of 18,

    • Those who do not speak Turkish,

    • Presence of deformities in the nose and forehead,

    • Those with nail polish and henna on their nails

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa Yuksek Ihtisas Education and Research Hospital Bursa Yıldırım Turkey 16310

    Sponsors and Collaborators

    • Bursa Yüksek İhtisas Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Canan Yılmaz, Department of Anesthesiology and Reanimation Director, Bursa Yüksek İhtisas Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04622436
    Other Study ID Numbers:
    • 2011-KAEK-25 2020/09-03
    First Posted:
    Nov 10, 2020
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Canan Yılmaz, Department of Anesthesiology and Reanimation Director, Bursa Yüksek İhtisas Education and Research Hospital
    Hypoxia
    Desaturation
    MicroStream Capnography
    Pulseoxymeter
    Additional relevant MeSH terms:
    Hypoxia

    Study Results

    No Results Posted as of Nov 10, 2020