NCT03039881

Brief Summary

This observational study investigates the validity and utility of a new, non-significant risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients undergoing elective surgery under general anesthesia. The study patients will be monitored before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for the first post-operative night. The physiologic data will not be used or influence the standard of care for subjects. It is anticipated that this monitor may be able to improve perioperative care in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

January 27, 2017

Last Update Submit

January 8, 2019

Conditions

Monitoring for Low Minute Ventilation Post Surgery

Keywords

Minute ventilation, ExSpiron monitor

Outcome Measures

Primary Outcomes (1)

  • Low minute ventilation

    Low minute ventilation (LMV) defined as sustained LMV\<40% minute ventilation predicted (MVPRED) based on IBW following opioid administration correlates with adverse clinical outcomes in PACU and on the floor

    Post-operatively in PACU and general patient' floor up to 24 hours after completion of surgery

Interventions

Non-Invasive Respiratory Volume MonitorDEVICE

The device requires the application of a monitoring PadSets to the patient's skin similar to EKG electrodes and, as such, poses minimal risk.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective surgery with general anesthesia

You may qualify if:

  • Adult patients undergoing surgery with general anesthesia and positive pressure ventilation, patient's ≥80 pounds and who are able to give informed consent.

You may not qualify if:

  • Patients unable to give informed consent. Any patient whose condition or procedure will not allow for placement of the electrode PadSet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Study Officials

  • Iwona Bonney, PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 1, 2017

Study Start

January 9, 2015

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)