The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

NCT02899351 | Completed

• 1 other identifier: IRB-P00023229
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Complications

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Infants less than 12 months

intubated infants in ICU

Device: Respiratory Volume Monitor

Interventions

Respiratory Volume Monitor DEVICE

Also known as: ExSpiron

Infants less than 12 months

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Intubated infants less than 12 months of age who are admitted to an Intensive Care Unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Atkinson DB, Sens BA, Bernier RS, Gomez-Morad AD, Imsirovic J, Nasr VG. The Evaluation of a Noninvasive Respiratory Volume Monitor in Mechanically Ventilated Neonates and Infants. Anesth Analg. 2022 Jan 1;134(1):141-148. doi: 10.1213/ANE.0000000000005562.

  PMID: 33929346 DERIVED

Study Officials

• Viviane Nasr, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

US (1)