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

NCT ID: NCT05548400

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Critical Illness Nutritional Imbalance

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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 2022.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliana P Antonio, PhD

Role: PRINCIPAL_INVESTIGATOR

HCPorto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Juliana P Antonio, PhD

Role: CONTACT

+555133598530

Ana Carolina P Antonio, PhD

Role: CONTACT

+555133598000

Facility Contacts

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Juliana P Antonio

Role: primary

+ 55 51 3359 8530

Other Identifiers

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2022-0070

Identifier Type: -

Identifier Source: org_study_id

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