Nutrition Under Noninvasive Ventilation

Completed

• Conditions: Nutrition Therapy; Respiratory Insufficiency; Noninvasive Ventilation

• Registration Number: NCT06260202
• Lead Sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-15
• Study Start: 2024-03-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caloric and protein gap	At ICU discharge, a median of six days	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

Secondary Outcome Measures

Name	Time	Method
Nutrition modalities outcomes	At ICU discharge, a median of six days	to evaluate the difference of the mean caloric and protein intake among groups of patients undergoing different nutritional modality

Trial Locations

Locations (1)

Università del Piemonte Orientale; 🇮🇹 Novara, Italy