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Alternate Methodology of Pulse Oximeter Validation

NCT03628560 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-08

No results posted yet for this study

Summary

This study will determine if the replacement of the measured arterial blood oxygen saturation with expired (end-tidal) oxygen value is an acceptable method to calculate the accuracy of pulse oximeters.

Conditions

  • Hypoxemia
  • Desaturation of Blood

Interventions

DEVICE

RespirAct Step-Wise Normocapnia desaturation sequence

Blood carbon dioxide controlled at normal value (normocapnia).

DEVICE

RespirAct Slope Normocapnia desaturation sequence

Blood carbon dioxide controlled at normal value (normocapnia).

DEVICE

RespirAct Step-Wise Hypocapnia desaturation sequence

Blood carbon dioxide controlled at lower than normal value (hypocapnia).

DEVICE

RespirAct Slope Hypocapnia desaturation sequence

Blood carbon dioxide controlled at lower than normal value (hypocapnia).

DEVICE

ROBD Step-Wise desaturation sequence

Blood carbon dioxide is controlled at normal or lower value by subject's own breathing rate.

Sponsors & Collaborators

Principal Investigators

  • David B MacLeod, FRCA · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2023-01-30
Completion
2023-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628560 on ClinicalTrials.gov