Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients

NCT ID: NCT02940938

Last Updated: 2017-06-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to evaluate the variations of respiratory changes in pulse oximeter plethysmographic amplitude (delta POP) according to different contact forces between finger and sensor of pulse oximeter. During general anesthesia without surgical stimuli, pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N (increased by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be calculated and compared.

Detailed Description

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Conditions

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Children Under General Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children under general anesthesia

During general anesthesia without surgical stimuli, pulse oximeter sensor is applied with gradually increased contact force, from 0 to maximal 1.5N (increase by about 0.2N), at an index finger and POP waveform is obtained for 60 seconds at each contact force. Delta POP will be calculated and compared.

Group Type EXPERIMENTAL

Applying pulse oximeter sensor

Intervention Type OTHER

During general anesthesia, pulse oximeter sensor is applied with gradually increased contact force, from 0 to 1.5N (increase by about 0.2N), at an index finger and POP waveform is obtained for 60 seconds.

Interventions

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Applying pulse oximeter sensor

During general anesthesia, pulse oximeter sensor is applied with gradually increased contact force, from 0 to 1.5N (increase by about 0.2N), at an index finger and POP waveform is obtained for 60 seconds.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* children who are aged between 2 and 5 years
* no cardiopulmonary and vascular diseases
* obtained written informed consent from their guardians
* no hemodynamic instability from massive bleeding

Exclusion Criteria

* significant cardiopulmonary or vascular disease
* significant hemodynamic instability due to massive bleeding etc.
* cyanotic patients
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SNUH

Seoul, Jongro Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee-Soo Kim, MD, PhD

Role: CONTACT

Facility Contacts

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Hee-Soo Kim, M.D., PhD

Role: primary

82-2-2072-3659

Other Identifiers

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H1609-067-791

Identifier Type: -

Identifier Source: org_study_id

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