Noninvasive VentilationNUTRINIVNCT06260202
Nutrition Under Noninvasive Ventilation
An observational study of Noninvasive Ventilation and Nutrition Therapy, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Nutrition Therapy, Respiratory Insufficiency
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age;
- Duration of noninvasive ventilation treatment of less than two days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Under Noninvasive Ventilation in Critically Ill Patients: a Retrospective Monocentric Analysis
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.
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At ICU discharge, a median of six days
Secondary outcomes (1)
Nutrition modalities outcomes
to evaluate the difference of the mean caloric and protein intake among groups of patients undergoing different nutritional modality
Measured: At ICU discharge, a median of six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Mar 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Moretto, Università degli Studi del Piemonte Orientale Amedeo Avogadro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260202
- Sponsor's protocol ID
- 308.273
- Acronym
- NUTRINIV
- Status last verified
- Dec 2024
- First submitted
- 29 Jan 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moretto F, Esposito T, Verdina F, Fracazzini M, Bertali L, Donnarumma M, Magli AL, Minelli F, Zuliani M, Barone B, Scotti L, Riso S, Umbrello M, Guido S, Prato F, Cammarota G, Vaschetto R. Nutritional strategies for noninvasively ventilated critically ill patients: results from the NUTRINIV retrospective study. BMC Nutr. 2026 Feb 19;12(1):58. doi: 10.1186/s40795-026-01271-x.
PubMed 41709358
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Under Noninvasive Ventilation in Critically Ill Patients: a Retrospective Monocentric Analysis
- ClinicalTrials.gov ID
- NCT06260202
- Acronym / sponsor ID
- NUTRINIV / 308.273
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under 18 years of age;
- Duration of noninvasive ventilation treatment of less than two days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Nutrition modalities outcomes
Time frame: At ICU discharge, a median of six days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 41709358Moretto F, Esposito T, Verdina F, Fracazzini M, Bertali L, Donnarumma M, Magli AL, Minelli F, Zuliani M, Barone B, Scotti L, Riso S, Umbrello M, Guido S, Prato F, Cammarota G, Vaschetto R. Nutritional strategies for noninvasively ventilated critically ill patients: results from the NUTRINIV retrospective study. BMC Nutr. 2026 Feb 19;12(1):58. doi: 10.1186/s40795-026-01271-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noninvasive Ventilation and Nutrition Therapy, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric and protein gap (time frame: At ICU discharge, a median of six days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.