Early Recognition of Hypoxia in Pediatric Patient Sedation

November 3, 2020 updated by: Canan Yılmaz, Bursa Yüksek İhtisas Education and Research Hospital

Comparison of MicroStream Capnography and Pulseoxymeter in Sedation of Pediatric Patients Undergoing Magnetic Resonance Imaging

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yıldırım
      • Bursa, Yıldırım, Turkey, 16310
        • Bursa Yüksek İhtisas Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients under ages 18

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early recognition of hypoxia
Time Frame: during the procedure
The rapid recognition of hypoxia that may occur with the initiation of the procedure
during the procedure
the changes in partial oxygen saturation
Time Frame: during the procedure
The rapid recognition of changes in partial oxygen saturation
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation score
Time Frame: during the procedure
Monitoring ramsey sedation scale. The minimum value is 1 and the maximum value is 6. Higher score means more sedatized.
during the procedure
recovery time
Time Frame: immediately after the procedure
length of stay in the recovery room
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2020/09-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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