NCT03870373

Brief Summary

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 8, 2019

Last Update Submit

March 29, 2021

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Performance of Pulse Oximeter Sensor in Neonates

    Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)

    Data are collected anywhere from the beginning of surgery until the completion of the procedure

Study Arms (1)

Test Subject

neonatal patients undergoing complex cardiac surgical procedures

Device: Pulse Oximeter

Interventions

Pulse OximeterDEVICE

Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.

Test Subject

Eligibility Criteria

Age0 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonatal patients undergoing complex cardiac surgical procedures.

You may qualify if:

  • Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
  • Consent signed by at least one legal guardian

You may not qualify if:

  • Presence of any skin irritation or breakdown on the foot
  • Foot impediments which would preclude proper placement of the sensor
  • Clinical condition precluding the use of adhesive materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

Study Officials

  • Hung G Nguyen, MD

    UCSF Medical Center at Mission Bay

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

February 1, 2019

Primary Completion

May 5, 2019

Study Completion

May 10, 2019

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

US(1)