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The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02899351
Enrollment
30
Registered
2016-09-14
Start date
2016-12-31
Completion date
2020-12-31
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Complications

Brief summary

In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation). It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected. The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.

Interventions

DEVICERespiratory Volume Monitor

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

Inclusion criteria

* less than 12 months of age * currently intubated in the ICU

Exclusion criteria

* ExSpiron monitor will interfere with a healing surgical procedure site or standard of care

Design outcomes

Primary

MeasureTime frame
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilationDuring 1 hour period in ICU
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilationDuring 1 hour period in ICU
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilationDuring 1 hour period in ICU

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026