Critical IllnessNCT05548400
Energy and Protein Adequacy of Oral Intake After Ventilator Withdrawal Among Critically Ill Patients.
An observational study of Critical Illness and Nutritional Imbalance, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Nutritional Imbalance
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted in the intensive care unit of a general university hospital in southern Brazil.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Juliana P Antonio, + 55 51 3359 8530, juantonio@hcpa.edu.br
About this study
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.
Read the 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.
- Conditions
- Critical Illness, Nutritional Imbalance
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Mar 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana P Antonio, PhD, Principal investigator, HCPorto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548400
- Sponsor's protocol ID
- 2022-0070
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy and Protein Adequacy of Oral Intake After Ventilator Withdrawal Among Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT05548400
- Acronym / sponsor ID
- 2022-0070
- Conditions
- Critical Illness, Nutritional Imbalance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted in the intensive care unit of a general university hospital in southern Brazil.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adequacy of oral intake after extubation on critical ill patients
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana P Antonio, PhD principal investigator
HCPorto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Nutritional Imbalance, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana P Antonio, PhD (+555133598530, juantonio@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of oral intake after extubation on critical ill patients (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.