The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

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.

Completed

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Key information

Conditions

Respiratory Complications

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Volume Monitor

Device

Other names: ExSpiron

Primary outcomes

Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation

Time frame: During 1 hour period in ICU
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation

Time frame: During 1 hour period in ICU
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation

Time frame: During 1 hour period in ICU

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 14, 2016
Registry last updated: Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed