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

Children Under General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940938
• Other study ID #: H1609-067-791
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: June 23, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, MD, PhD
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Children Under General Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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