NCT04622436

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

October 16, 2020

Last Update Submit

November 3, 2020

Conditions

Desaturation of Blood

Keywords

HypoxiaDesaturationMicroStream CapnographyPulseoxymeter

Outcome Measures

Primary Outcomes (2)

  • Early recognition of hypoxia

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

    during the procedure

  • the changes in partial oxygen saturation

    The rapid recognition of changes in partial oxygen saturation

    during the procedure

Secondary Outcomes (2)

  • Sedation score

    during the procedure

  • recovery time

    immediately after the procedure

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric patients under ages 18

You may qualify if:

  • Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Education and Research Hospital

Bursa, Yıldırım, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Reanimation Director

Study Record Dates

First Submitted

October 16, 2020

First Posted

November 10, 2020

Study Start

October 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

TU(1)