NCT03628560

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

4.3 years

First QC Date

August 9, 2018

Last Update Submit

February 21, 2022

Conditions

HypoxemiaDesaturation of Blood

Keywords

Healthy volunteerOximetryPulse oximeterHypoxia

Outcome Measures

Primary Outcomes (2)

  • Accuracy of FDA-approved pulse oximeter when calculated with RespirAct-derived end-tidal PAO2 values and with co-oximeter measured arterial PaO2 values

    The unit of measure of accuracy is called A\[RMS\] and is a composite value of bias and precision.

    1 study day

  • PAO2 values

    RespirAct-derived end-tidal PAO2 values with co-oximeter measured arterial PaO2 values

    1 study day

Secondary Outcomes (2)

  • Accuracy, A[RMS], when a step-wise desaturation sequence is used against a slope desaturation sequence.

    1 study day

  • Level of PaCO2 (hypocapnia versus normocapnia)

    1 study day

Study Arms (5)

RespirAct Step-Wise Normocapnia desaturation sequence

EXPERIMENTAL

Reduction in oxygen saturation 100 to 70% in approximate 5% steps.

Device: RespirAct Step-Wise Normocapnia desaturation sequence

RespirAct Slope Normocapnia desaturation sequence

EXPERIMENTAL

Reduction in oxygen saturation 100 to 70% as gradual slope.

Device: RespirAct Slope Normocapnia desaturation sequence

RespirAct Step-Wise Hypocapnia desaturation sequence

EXPERIMENTAL

Reduction in oxygen saturation 100 to 70% in approximate 5% steps.

Device: RespirAct Step-Wise Hypocapnia desaturation sequence

RespirAct Slope Hypocapnia desaturation sequence

EXPERIMENTAL

Reduction in oxygen saturation 100 to 70% as gradual slope.

Device: RespirAct Slope Hypocapnia desaturation sequence

ROBD Step-Wise desaturation sequence

ACTIVE COMPARATOR

ROBD = Reduced Oxygen Breathing Device. Reduction in oxygen saturation 100 to 70% in approximate 5% steps. This represents the standard type of desaturation sequence for pulse oximeter accuracy testing.

Device: ROBD Step-Wise desaturation sequence

Interventions

RespirAct Step-Wise Normocapnia desaturation sequenceDEVICE

Blood carbon dioxide controlled at normal value (normocapnia).

RespirAct Step-Wise Normocapnia desaturation sequence
RespirAct Slope Normocapnia desaturation sequenceDEVICE

Blood carbon dioxide controlled at normal value (normocapnia).

RespirAct Slope Normocapnia desaturation sequence
RespirAct Step-Wise Hypocapnia desaturation sequenceDEVICE

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

RespirAct Step-Wise Hypocapnia desaturation sequence
RespirAct Slope Hypocapnia desaturation sequenceDEVICE

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

RespirAct Slope Hypocapnia desaturation sequence
ROBD Step-Wise desaturation sequenceDEVICE

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

ROBD Step-Wise desaturation sequence

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 - 50 years
  • Subject is willing to provide written informed consent and is able to comply with anticipated study procedures

You may not qualify if:

  • Body Mass Index (BMI) \< 18.0 or \> 30.0
  • Known significant respiratory, cardiovascular or medical condition that precludes study participation as judged by investigator
  • Anemia \[hemoglobin value below lower range of normal for gender\]
  • Abnormal hemoglobin electrophoresis result
  • Exposure to nicotine \[positive test at screening or study day\]
  • Abnormal drug screen \[positive test at screening or on day of study\]
  • Positive pregnancy test for females \[serum test at screening; urine test on study day\]
  • Abnormal Allen's test for collateral circulation
  • Abnormal Electrocardiogram
  • Abnormal Pulmonary Function Test
  • Abnormal venous blood gas result
  • Intolerance of facemask

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Links

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David B MacLeod, FRCA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

September 26, 2018

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)