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

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.

Study Overview

• Status: Unknown
• Conditions: Children Under General Anesthesia
• Intervention / Treatment: Other: Applying pulse oximeter sensor

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee-Soo Kim, MD, PhD; Email: dami0605@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongro Gu
    • Seoul, Jongro Gu, Korea, Republic of, 15710
      • Recruiting
      • SNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: H1609-067-791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No