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

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ClinicalTrials.gov Identifier: NCT02940938
Recruitment Status : Unknown
Verified December 2016 by Hee-Soo Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 21, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, 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.

Condition or disease Intervention/treatment Phase
Children Under General Anesthesia Other: Applying pulse oximeter sensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients: the Effect of Contacting Force
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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.




Primary Outcome Measures :
  1. Respiratory changes in pulse oximeter plethysmographic amplitude measured [ Time Frame: 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 :
  1. Amplitude of pulse oximeter plethysmography [ Time Frame: about 3 minutes after anesthetic induction without surgical stimuli ]
    Amplitude of pulse oximeter plethysmography measured by pulse oximeter sensor with different contact force



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940938


Contacts
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Contact: Hee-Soo Kim, MD, PhD dami0605@snu.ac.kr

Locations
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Korea, Republic of
SNUH Recruiting
Seoul, Jongro Gu, Korea, Republic of, 15710
Contact: Hee-Soo Kim, M.D., PhD    82-2-2072-3659    dami0605@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02940938     History of Changes
Other Study ID Numbers: H1609-067-791
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No