Perioperative Complications of Deep Extubation in Adults

Sponsor
Massachusetts Eye and Ear Infirmary (Other)
Overall Status
Completed
CT.gov ID
NCT04557683
Collaborator
(none)
300
1
22
13.6

Study Details

Study Description

Brief Summary

The investigators propose a prospective observational cohort study in order to investigate the perioperative respiratory complications of deep extubation in adults undergoing eye and head-and-neck surgery at Massachusetts Eye and Ear. Data pertaining to perioperative respiratory complications from adult patients presenting to MEE for eye and head and neck surgery who undergo deep extubation will be collected for this study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Perioperative Complications of Deep Extubation in Adults Undergoing Head and Neck Surgery at Massachusetts Eye and Ear Infirmary.
    Actual Study Start Date :
    May 1, 2017
    Actual Primary Completion Date :
    Oct 13, 2017
    Actual Study Completion Date :
    Mar 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Desaturation [1 hour]

      Desaturation to less than 95% for more than 10 seconds;

    2. Cough [1 hour]

      Episodes of persistent cough, defined as 3 or more consecutive coughs

    3. Laryngospasm [1 hour]

      Episodes of complete or partial laryngospasm

    4. Bronchospasm [1 hour]

      Episodes of bronchospasm

    5. Negative pressure pulmonary edema [1 hour]

      Incidence of negative pressure pulmonary edema

    6. Interventions [1 hour]

      Obstruction that requires intubation or maneuvers, oral airway or jaw thrust

    Secondary Outcome Measures

    1. Length of time from the end of surgery to leaving the OR [1 hour]

    Other Outcome Measures

    1. Length of stay from admission to the PACU to discharge home [1-3 hours]

    2. Any unplanned hospital admission due to perioperative respiratory adverse events [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult men and women who present to MEE for eye and head-and-neck surgery and undergo deep extubation will be included.
    Exclusion Criteria:
    • The study does not exclude anyone from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts Eye and Ear Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Massachusetts Eye and Ear Infirmary

    Investigators

    • Principal Investigator: Martha Cordoba, MD, Massachusetts Eye and Ear

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Jeremy Juang, Anesthesiologist, Massachusetts Eye and Ear Infirmary
    ClinicalTrials.gov Identifier:
    NCT04557683
    Other Study ID Numbers:
    • 1047249
    First Posted:
    Sep 22, 2020
    Last Update Posted:
    Sep 23, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 23, 2020