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HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

Sponsor
Jubilee Mission Medical College and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05954533
Collaborator
(none)
192
Enrollment
1
Location
18
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ED. Indeed, the proportion of difficult intubation ranges from 10% to 27% in the ED setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. Because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ED patients is critical. The commonest airway prediction tool is the LEMON score. In the modified LEMON score "Mallampati" was excluded as it was not a pragmatic assessment in the ED.

Existing difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. LEMON criteria was designed for preoperative clinical setting.

Hence in this study we are observing if HEAVEN (H- Hypoxemia E - extremes of age A - anatomical abnormalities V - vomit/ blood / fluid E - Exsanguination/anaemia N - neck mobility issues) is a better tool for predicting difficult intubatio.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    192 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cross Sectional Study to Determine Whether HEAVEN CRITERIA is a Better Tool Than Modified LEMON Score for Predicting Difficult Intubation in In-hospital Emergency Airway Management
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. First attempt intubation success rate [Two hours]

    2. Physicians assessment of intubation as easy or difficult [Two hours]

    Secondary Outcome Measures

    1. Total attempts of intubation. [Two hours]

    2. Patients requiring vasoconstrictors undergoing endotracheal intubation [Two hours]

    3. Patients requiring rescue airway devices ( eg.LMA) / emergency front of neck access. [Two hours]

    4. Patients with suspicion of aspiration during endotracheal intubation [Two hours]

    5. Which criteria was the most frequent in causing difficult airway among HEAVEN [Two hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. All patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent
    Exclusion Criteria:
    • Patients not consenting for the study or ยท Patients in cardio respiratory arrest

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 JMMCRI Thrissur Kerala India 680005

    Sponsors and Collaborators

    • Jubilee Mission Medical College and Research Institute

    Investigators

    • Study Director: DR APPU SUSEEL, MBBS,MD, JMMCRI
    • Study Director: DR SIJU V ABRAHAM, MBBS,MD, JMMCRI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Jaismol James, Junior Resident, Jubilee Mission Medical College and Research Institute
    ClinicalTrials.gov Identifier:
    NCT05954533
    Other Study ID Numbers:
    • 39/22/IEC/JMMC&RI
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Jaismol James, Junior Resident, Jubilee Mission Medical College and Research Institute
    HEAVEN criteria
    Modified LEMON
    Difficult airway
    Prediction tool

    Study Results

    No Results Posted as of Jul 20, 2023