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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548400
• Other study ID #: 2022-0070
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Juliana P Antonio, PhD
• Phone: +555133598530
• Email: juantonio[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Nutritional Imbalance

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of oral intake after extubation on critical ill patients	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.	7 months