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

Not Applicable

• Conditions: Children Under General Anesthesia
• Interventions: Other: Applying pulse oximeter sensor

• Registration Number: NCT02940938
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Status Verified: 2016-12
• Study Start: 2017-01
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-27
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children under general anesthesia	Applying pulse oximeter sensor	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.

Primary Outcome Measures

Name	Time	Method
Respiratory changes in pulse oximeter plethysmographic amplitude measured	about 3 minutes after anesthetic induction without surgical stimuli	Respiratory changes in pulse oximeter plethysmographic amplitude measured by pulse oximeter sensor with different contact force

Secondary Outcome Measures

Name	Time	Method
Amplitude of pulse oximeter plethysmography	about 3 minutes after anesthetic induction without surgical stimuli	Amplitude of pulse oximeter plethysmography measured by pulse oximeter sensor with different contact force

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of