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Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

Sponsor
Qassim University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06005701
Collaborator
(none)
470
Enrollment
1
Location
20.9
Anticipated Duration (Months)
22.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A preoperative assessment by anaesthetic staff should include the Mallampati Score, as there is a direct correlation between the amount of space in the pharynx and the laryngoscopic view during intubation which has been refined by Cormack and Lehane (1984) Clinical diagnosis one of most important factor indicating the postoperative complications like Mallampati score. As the Mallampati class zero per se is not indicating with any difficulty of airway management unless other airway characteristics indicating to the difficulty. As well as if the epiglottis may be large and overhanging, it's not common with airway difficulty in Mallampati class zero airway.

    The Mallampati score idea is to estimate the size of the tongue related to the oral cavity and the displacement of the tongue by the laryngoscope blade was likely to be easy or difficult. It also assessed whether the mouth could be opened adequately to permit intubation

    Research objectives To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

    Method:

    Observational, Multi hospital, Regional Study

    Inclusion Criteria:

    1. Age: 20 - 50 years

    2. Laparoscopic Cholecystectomy Surgery

    3. Body Mass Index (BMI): ≤ 35

    Exclusion Criteria:

    1. Age Less than 20 years

    2. Age More than 50 years

    3. Body Mass Index (BMI) > 35

    Data management and analysis plan:

    All data will be entered and analyzed using SPSS V28© (IBM Corp., Armonk, NY, USA). Categorical variables will have expressed as frequencies and percentages, while continuous variables will have presented as means ± standard deviations (SDs). The chi-squared test will have used to evaluate demographic and health-related characteristics associated with name of the clinic as well as type of service provided to the patient. A p-value of less than 0.05 was considered to be statistically significant

    Ethical considerations:

    • All investigators completed the Bioethics certificate from The National Committee of Bioethics at King Abdulaziz City for Science and Technology.

    • All investigators declare there is no conflict of interest.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    470 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Surveillance [3 months]

      predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age: 20 - 50 years

    2. Laparoscopic Cholecystectomy Surgery

    3. Body Mass Index (BMI): ≤ 35

    Exclusion Criteria:

    1. Age Less than 20 years

    2. Age More than 50 years

    3. Body Mass Index (BMI) > 35

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qassim University Medical City Buraidah Qassim Saudi Arabia 51411

    Sponsors and Collaborators

    • Qassim University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammed Abaalkhayl, Assistant Professor, Qassim University
    ClinicalTrials.gov Identifier:
    NCT06005701
    Other Study ID Numbers:
    • 23-33-05
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohammed Abaalkhayl, Assistant Professor, Qassim University
    Mallampati Score
    Surgery
    Anesthesia
    Additional relevant MeSH terms:
    Cholecystitis
    Cholestasis

    Study Results

    No Results Posted as of Aug 28, 2023