NCT05548400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 6, 2022

Last Update Submit

September 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically ill patients admitted in the intensive care unit of a general university hospital in southern Brazil.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juliana P Antonio, PhD

    HCPorto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana P Antonio, PhD

CONTACT

Ana Carolina P Antonio, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 21, 2022

Study Start

March 1, 2022

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations