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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità degli Studi del Piemonte Orientale Amedeo Avogadro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Food diary

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 1 treatment group
Group A: Noninvasively ventilated patients1 intervention

Trial outcomes

Primary outcomes

1

Caloric intake

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

Time frame
Data will be collected on a daily food diary for five days from the start of noninvasive ventilation treatment
2

Protein intake

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

Time frame
Data will be collected on a daily food diary for five days from the start of noninvasive ventilation treatment
3

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.

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

Secondary outcomes

1

Risk factors for undernutrition

Evaluation of potential associations between patient clinical and nutritional characteristics and undernutrition

Time frame
This evaluation will consider undernutrition as a dichotomous outcome during the five days of data collection
2

Noninvasive ventilation complications

Occurrence of noninvasive ventilation treatment-related complications

Time frame
Complication occurrence will be evaluated during the five days of data collection
3

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, according to the type of respiratory failure, hypoxemic vs hypoxemic-hypercapnic.

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

Other outcomes

Sponsors and contacts

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