The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Completed

• Conditions: Respiratory Complications
• Interventions: Device: Respiratory Volume Monitor

• Registration Number: NCT02899351
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Study Start: 2016-12
• Primary Completion: 2020-09
• Study Completion: 2020-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants less than 12 months	Respiratory Volume Monitor	intubated infants in ICU

Primary Outcome Measures

Name	Time	Method
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation	During 1 hour period in ICU
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation	During 1 hour period in ICU
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation	During 1 hour period in ICU

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States