The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

NCT ID: NCT02899351

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Respiratory Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants less than 12 months

intubated infants in ICU

Respiratory Volume Monitor

Intervention Type DEVICE

Interventions

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Respiratory Volume Monitor

Intervention Type DEVICE

Other Intervention Names

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ExSpiron

Eligibility Criteria

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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
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Viviane Nasr

Cardiac Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viviane Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33929346 (View on PubMed)

Other Identifiers

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IRB-P00023229

Identifier Type: -

Identifier Source: org_study_id

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