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

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Seoul National University

Status

Unknown

Conditions

Children Under General Anesthesia

Treatments

Other: Applying pulse oximeter sensor

Study type

Interventional

Funder types

Other

Identifiers

NCT02940938
H1609-067-791

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

2 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Children under general anesthesia
Experimental group
Description:
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.
Treatment:
Other: Applying pulse oximeter sensor

Trial contacts and locations

1

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Central trial contact

Hee-Soo Kim, MD, PhD

Data sourced from clinicaltrials.gov

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