Expired Study
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Boston, Massachusetts 02116


Purpose:

Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.


Criteria:

Inclusion Criteria: - pediatric patients between the ages of 1 year and 17 years - ASA status of 1-3 - scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital Exclusion Criteria: - Patients undergoing an emergency procedure or a - patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care - preexisting respiratory disease - muscular disease affecting the respiratory system


Study is Available At:


Original ID:

IRB-P00015003


NCT ID:

NCT02336022


Secondary ID:


Study Acronym:


Brief Title:

The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia


Official Title:

The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

1 Year


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Boston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

90


Enrollment Type:

Actual


Overall Contact Information

Official Name:Viviane Nasr
Principal Investigator
Children's Hospital Boston

Study Dates

Start Date:March 2015
Completion Date:May 2016
Completion Type:Actual
Primary Completion Date:May 2016
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 26, 2016
First Received Date:December 15, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.
Time Frame:intraoperative
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.
Time Frame:intraoperative
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.
Time Frame:intraoperative
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Respiratory Motion Inc

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Boston

Samples and Retentions

Study Population: Patients undergoing general anesthesia for surgical procedures at Boston Children's Hospital.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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