Energy and Protein Adequacy of Oral Intake After Ventilator Withdrawal Among Critically Ill Patients.

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05548400
Collaborator
(none)
50
1
10
5

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the adequacy of exclusive oral intake, in terms of energy-protein amount, after extubation in critically ill patients who remained on invasive mechanical ventilation for at least 48 hours.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A prospective observational study. The adequacy of exclusive oral consumption will be assessed in a consecutive sample of critically ill patients after ventilator removal by visual intake scale in 0%, 25%, 50%, 75%, or 100% of principal meals, i.e., lunch and dinner, during seven days after recruitment.

    To characterize the study population, general characteristics of patients and their hospital outcomes will be collected: sociodemographic (age, sex, ethnicity, education) and admission clinical data (weight, height, Simplified Acute Physiology Score 3, Nutritional Risk Screening, and Subjective Global Assessment), energy and protein intake within 72 hours after initiation of invasive mechanical ventilation, the underlying disease that led to hospitalization, length of stay in the ICU, length of invasive mechanical ventilation and hospital stay, the incidence of infections after ICU discharge and in-hospital death.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Energy and Protein Adequacy of Oral Intake After Ventilator Withdrawal Among Critically Ill Patients.
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Oct 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Criticaly ill patients who remained on invasive mechanical ventilation for at least 48 hours.

    Criticaly ill patients who remained on invasive mechanical ventilation for at least 48 hours, and dietary followed up after ventilator withdrawal.

    Outcome Measures

    Primary Outcome Measures

    1. Adequacy of oral intake after extubation on critical ill patients [7 months]

      Oral food intake by an adapted visual intake scale in which the patient or nursing team will indicate intake at 0%, 25%, 50%, or 75 to 100% of principal meals, i.e., lunch and dinner, during seven days after recruitment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Adult critically ill patients

    • Mechanical ventilation for at least 48 hours and who migrate to exclusively oral feeding within seven days after extubation without receiving complementary parenteral or enteral nutrition.

    • Admitted to the ICU in Hospital de Clínicas de Porto Alegre from March 2022 to October

    Exclusion criteria:
    • Pregnancy

    • Occurrence of major abdominal surgery during ICU stay

    • Tracheostomized patients

    • Patients unable to start an oral diet after extubation.

    • Patients previously included in the study.

    • Patients seeking exclusive palliative care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-003

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Juliana P Antonio, PhD, HCPorto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT05548400
    Other Study ID Numbers:
    • 2022-0070
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2022