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The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02899351
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Viviane Nasr, Boston Children's Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Respiratory Complications Device: Respiratory Volume Monitor

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Actual Study Start Date : December 2016
Actual Primary Completion Date : September 2020
Actual Study Completion Date : December 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Infants less than 12 months
intubated infants in ICU
 Device: Respiratory Volume Monitor
Other Name: ExSpiron


Outcome Measures
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Primary Outcome Measures :
  1. Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation [ Time Frame: During 1 hour period in ICU ]
  2. Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation [ Time Frame: During 1 hour period in ICU ]
  3. Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation [ Time Frame: During 1 hour period in ICU ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated infants less than 12 months of age who are admitted to an Intensive Care Unit
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899351


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Viviane Nasr, MD Boston Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Viviane Nasr, Cardiac Anesthesiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02899351    
Other Study ID Numbers: IRB-P00023229
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021