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

Study Overview
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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.

Official Title
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Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients: the Effect of Contacting Force

Conditions
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Children Under General Anesthesia

Intervention / Treatment
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* Other: Applying pulse oximeter sensor


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children under general anesthesia<br>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. | Other: Applying pulse oximeter sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory changes in pulse oximeter plethysmographic amplitude measured | Respiratory changes in pulse oximeter plethysmographic amplitude measured by pulse oximeter sensor with different contact force | about 3 minutes after anesthetic induction without surgical stimuli | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of pulse oximeter plethysmography | Amplitude of pulse oximeter plethysmography measured by pulse oximeter sensor with different contact force | about 3 minutes after anesthetic induction without surgical stimuli |