Nutritional Intake in Patients on Noninvasive Ventilation: a Prospective Observational Study

NCT06740981 | Not Yet Recruiting

• 1 other identifier: CE309/2024
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to quantify the caloric and protein intake in adult participants with acute respiratory failure who start a noninvasive ventilation treatment. The main question is: \- Are participants meeting their caloric and protein target during noninvasive ventilation treatment? Participants will complete a five-day food diary collection starting from the initiation of noninvasive ventilation treatment.

Conditions

Malnutrition or Risk of Malnutrition; Acute Respiratory Failure

Keywords

noninvasive ventilation; nutrition; critical illness

Outcome Measures

Primary Outcomes (3)

• Caloric intake

  Analysis of daily caloric intake per kilogram in patients undergoing noninvasive ventilation for acute respiratory failure

  Data will be collected on a daily food diary for five days from the start of noninvasive ventilation treatment

• Protein intake

  Analysis of daily protein intake per kilogram in patients undergoing noninvasive ventilation for acute respiratory failure.

  Data will be collected on a daily food diary for five days from the start of noninvasive ventilation treatment

• Caloric and protein adequacy

  Analysis of the discrepancy between patients' actual caloric and protein intake and the caloric and protein target recommended in the critically ill patients guidelines.

  Discrepancy will be analyzed daily for five days from the start of noninvasive ventilation treatment

Secondary Outcomes (3)

• Risk factors for undernutrition

  This evaluation will consider undernutrition as a dichotomous outcome during the five days of data collection

• Noninvasive ventilation complications

  Complication occurrence will be evaluated during the five days of data collection

• Caloric and protein adequacy

  Discrepancy will be analyzed daily for five days from the start of noninvasive ventilation treatment

Study Arms (1)

Noninvasively ventilated patients

For patients admitted with acute respiratory failure requiring noninvasive ventilation, a food diary will be collected for five days.

Other: Food diary

Interventions

Food diary OTHER

A food and beverage diary will be collected for five days starting from the initiation of noninvasive ventilation, with caloric and protein intake quantified by a Nutrition Physician Specialist.

Noninvasively ventilated patients

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 participant wards, intermediate or intensive care units for acute respiratory failure from any cause, undergoing noninvasive ventilation within 24 hours from hospital admission and without exclusion criteria, will be considered for enrollment.

You may qualify if:

• Age of 18 years or more
• Hospitalization in the participant ordinary wards, intermediate care units and intensive care unit at the Maggiore della Carità University Hospital, Novara, Italy
• Admission for acute respiratory failure of any cause requiring noninvasive ventilation treatment within 24 hours from hospital admission

You may not qualify if:

• Palliative noninvasive ventilation treatment
• Contraindication to oral nutrition from hospital admission
• Patients admitted for surgical or gastroenterological diagnosis
• Severe immunocompromised patients or patients undergoing therapies contraindicating oral nutrition

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Novara, 28100, Italy

Location

MeSH Terms

Conditions

Malnutrition; Critical Illness

Interventions

Diet Records

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Records; Organization and Administration; Health Services Administration

Central Study Contacts

Francesca Moretto, Medical Doctor

CONTACT

003903213733380; francesca.moretto@uniupo.it

Study Design

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

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)