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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02940938

Enrollment

Registered

2016-10-21

Start date

2017-01-31

Completion date

2017-12-31

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Under General Anesthesia

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.

Interventions

OTHERApplying 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactHee-Soo Kim, MD, PhD

dami0605@snu.ac.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026