The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Respiratory Complications Clinical Trial

Official title:

The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899351
• Other study ID #: IRB-P00023229
• Status: Completed
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Complications

Intervention

Device:
• Respiratory Volume Monitor

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation		During 1 hour period in ICU
Primary	Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation		During 1 hour period in ICU
Primary	Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation		During 1 hour period in ICU