Nutrition Under Noninvasive Ventilation

NCT06260202 | Completed

• 1 other identifier: 308.273
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Noninvasive Ventilation; Nutrition Therapy; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nutrition modalities outcomes

  At ICU discharge, a median of six days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023, undergoing noninvasive ventilation for any diagnosis of acute respiratory failure and for any cause (to avoid endotracheal intubation, as alternative to invasive ventilation, as weaning from invasive ventilation) will be considered.

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 years of age;
• Duration of noninvasive ventilation treatment of less than two days.

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead

Study Sites (1)

Università del Piemonte Orientale

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 15, 2024
• Study Start: March 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

IT (1)