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Quality of Preoxygenation in Emergency Surgery

Sponsor
Vilnius University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04070404
Collaborator
(none)
200
Enrollment
1
Location
36
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.

The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.

    Parameters analysed:

    • Preoperative: medical history, physical examination, laboratory findings, anthropometric data

    • Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery
    Actual Study Start Date :
    May 1, 2019
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    May 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Efficient preoxygenation in preset time [300 seconds]

      End-tidal oxygen concentration values

    Secondary Outcome Measures

    1. Factors influencing preoxygenation quality [300 seconds]

      Medical history, physical status, lab findings, preoxygenation equipment and method

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • written informed consent

    • patient going for emergency surgery under general anaesthesia

    • age > 18 years

    Exclusion Criteria:

    • informed consent refusal

    • noneligible for preoxygenation before general anaesthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vilnius University Hospital Santaros Clinics Vilnius Lithuania

    Sponsors and Collaborators

    • Vilnius University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vilnius University
    ClinicalTrials.gov Identifier:
    NCT04070404
    Other Study ID Numbers:
    • 19BMT30
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vilnius University
    Anaesthesia
    Preoxygenation
    Additional relevant MeSH terms:
    Emergencies

    Study Results

    No Results Posted as of Oct 9, 2020