Skip to main content
OpenTrials
Completed

NCT Number: NCT06260202

Nutrition Under Noninvasive Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università del Piemonte Orientale

Novara, 28100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Caloric and protein gap

    Time frame: 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 outcomes

  1. Nutrition modalities outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Other

Registry information

Official study title

Nutrition Under Noninvasive Ventilation in Critically Ill Patients: a Retrospective Monocentric Analysis

Acronym: NUTRINIV

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.