Clincosm LogoSign in Get a demo

SEDLine: Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT02011607
Collaborator
(none)
500
Enrollment
1
Location
107
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. incidence of adverse events [during the procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All the patients considered as high risk (see above) or undergoing an advanced upper GI procedure (see above) will be included. This is the prospective analysis of the data that is collected and stored in the monitors. We will be using the massimo Pulse oximeter ,masimo acoustic respiratory monitor and Masimo SED line Brain function monitors that allows electronic storage and retrieval of information.

    • Postprocedure analysis of the data will not influence the patient care.

    Exclusion Criteria:

    • Any patient who cannot give a valid consent will be excluded

    • Children

    • Pregnant women

    • Fetuses and/or Neonates

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Basavana G Goudra, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02011607
    Other Study ID Numbers:
    • 812903
    First Posted:
    Dec 13, 2013
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021

    Study Results

    No Results Posted as of Feb 11, 2021