NCT02968797

Brief Summary

SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

September 7, 2016

Last Update Submit

March 20, 2018

Conditions

Apnea

Outcome Measures

Primary Outcomes (1)

  • Comparative data of monitoring respiratory by 2 technologies

    Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.

    4 months

Interventions

SafeSedDEVICE

Monitor respiratory parameters

Eligibility Criteria

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

Patients scheduled to perform endoscopy procedures under sedation

You may qualify if:

  • class 1-3 per American Society Anesthesiologists Physical Status Classification
  • Subject signed Informed Concent Form

You may not qualify if:

  • Pregnancy
  • Unresolved pulmonary infection requiring active treatment
  • Chronic pulmonary disease
  • Any othe medical condition, that treating physician determines participating in the study is unadvisable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 4428331, Israel

RECRUITING

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Fredman, MD

    Israel: Clalit Health bServices

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Fredman, MD

CONTACT

052-278-5127fredman.brian@clalit.org.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

November 21, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)