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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06260202
Other study ID # 308.273
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date May 31, 2024

Study information

Verified date February 2024
Source Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients; - Admission to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023; - Noninvasive ventilation treatment for acute respiratory failure of any cause; - Duration of noninvasive ventilation treatment of more than two days; - Informed consent signed. Exclusion Criteria: - Patients under 18 years of age; - Duration of noninvasive ventilation treatment of less than two days.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Outcome

Type Measure Description Time frame Safety issue
Primary Caloric and protein gap to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients for every day of ICU stay At ICU discharge, a median of six days
Secondary Nutrition modalities outcomes to evaluate the difference of the mean caloric and protein intake among groups of patients undergoing different nutritional modality At ICU discharge, a median of six days
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