INVSENSOR00013 Respiratory Rate Clinical Performance Study

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Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: INVSENSOR00013

Study type

Interventional

Funder types

Industry

Identifiers

NCT03440619
TP-18896

Details and patient eligibility

About

The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.

Enrollment

28 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 to 70 years old
  • Physical status of ASA I or II
  • Must be able to read and communicate in English
  • Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
  • Passed health assessment screening
  • Negative pregnancy test for female subjects of child bearing potential

Exclusion criteria

  • Physical status of ASA III, IV, or V
  • Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
  • Inability to tolerate sitting still or minimal movement for at least 30 minutes
  • Positive pregnancy test for female subjects
  • Refusal to take pregnancy test for women of child bearing potential
  • Nursing female subjects
  • Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
  • Subjects wearing acrylic nails or subjects refusing to remove nail polish
  • Subjects who have a nail deformity on the measurement finger
  • Subjects who do not have adequate skin integrity on the measurement finger
  • Excluded at the Principal Investigator's discretion

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

INVSENSOR00013 Test group
Experimental group
Description:
All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.
Treatment:
Device: INVSENSOR00013

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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