Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure

NCT07178483 | Active Not Recruiting

• 1 other identifier: NIVAR01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

NIVAR01 (Multimodal evaluation of physical capacity and energy requirements in patients with hypoxemic acute respiratory failure and community acquired pneumonia under non invasive ventilation support) aims to comprehensively assess energy requirements and physical capacity in patients with acute hypoxemic respiratory failure (AHRF) due to community-acquired pneumonia (CAP) undergoing non-invasive ventilation (NIV). Through a stepwise, multimodal approach integrating physiological measurements, imaging, and molecular biomarkers, the project seeks to identify patient subphenotypes that can guide targeted interventions, improve outcomes, and reduce the need for invasive mechanical ventilation. The project is structured in five progressive phases, each building on the findings of the previous one to refine and personalize care strategies. The first phase of the project aims to assess the correlation between BIA (bioelectrical impedance analysis) and IC (indirect calorimetry) in sedated patients, in oder to extrapolate this correlation in patients under NIV in the next phase. The second phase uses this correlation to validate the use of indirect calorimetry (IC) in patients under non-invasive ventilation (NIV) by comparing it with data obtained from patients under invasive mechanical ventilation, where IC is better established and technically more accurate. This comparative approach will serve to assess the reliability and feasibility of IC in NIV settings, incorporating correction factors for air leaks and comparing with BIA data, laying the groundwork for its integration with other physiological and biochemical measurements in subsequent phases. The third phase expands to a multimodal prospective observational cohort study integrating IC, BIA, ultrasound, biomarkers of mitochondrial and endothelial dysfunction, and innate immune system paralysis. These data will be used for patient phenotyping through advanced machine learning. The fourth and fifth phases will develop and test personalized nutritional and motor interventions (e.g., phrenic nerve stimulation, tailored physiotherapy) in clinical trials based on identified patient subtypes. Previous studies (Georges et al., Siirala et al., Singer 2024) have demonstrated the feasibility of using IC in NIV patients, although limited by methodological constraints. This project brings novelty by incorporating BIA-derived metabolic rate estimates and segmental analysis, offering new insights into body composition, fluid balance, and muscle integrity, including diaphragm function. Additionally, biomarkers such as cf-mtDNA, FGF-21, GDF-15, HSP60/10, and cytokine profiles (TNFα, IL-6, IL-10, CRP), as well as endothelial markers (e-Selectin, sICAM-1, vCAM-1, Syndecan-1), will be analyzed. Immune paralysis will be studied via monocyte HLA-DR expression and LPS-stimulated cytokine release. By leveraging multimodal data integration and gender-specific analysis, NIVAR 01 aims to optimize prediction of NIV failure beyond current tools such as the HACOR index and enable individualized patient management.

Conditions

Acute Hypoxemic Respiratory Failure; Non Invasive Ventilation (NIV); Bioimpedance Measurement Capacity; Calorimetry, Indirect; Muscular Ultrasound; Mitochondrial Biomarkers; Endotheliopathy; Immune Response; Community Acquired Pneumonia (CAP)

Keywords

NIV; ARF; BIOIMPEDANCIOMETRY; INDIRECT CALORIMETRY; CAP

Outcome Measures

Primary Outcomes (1)

• NIV FAILURE

  ENDOTRACHEAL INTUBATION OR DEATH WHILE RECEIVING NIV

  1 MONTH

Secondary Outcomes (2)

• ICU LENGHT OF STAY

  Through study completion, an average of 1 year

• HOSPITAL LENGTH OF STAY

  Through study completion, an average of 1 year.

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

Patients admitted to critical care units requiring NIV support due to CAP and hypoxemic acute respiratory failure.

You may qualify if:

• Moderate-to-severe Acute Hypoxemic Respiratory Failure (PaO2 /FiO2 \< 200mmHg) due to respiratory infection who underwent NIV support for at least 24h.

You may not qualify if:

• Presence of electrical implants, wounds or skin damage at the designated electrode sites or the inability to perform BIA.
• Patients who met criteria for immediate intubation upon ICU admission were also excluded.
• Other circumstances or clinical conditions at the discretion of the investigator that precluded the participation of the patient in the study were also considered (i.e., limitation of therapeutic effort and poor prognosis).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

• Moonen HPFX, Van Zanten ARH. Bioelectric impedance analysis for body composition measurement and other potential clinical applications in critical illness. Curr Opin Crit Care. 2021 Aug 1;27(4):344-353. doi: 10.1097/MCC.0000000000000840.

  PMID: 33967207 BACKGROUND

• Cunningham JJ. Body composition as a determinant of energy expenditure: a synthetic review and a proposed general prediction equation. Am J Clin Nutr. 1991 Dec;54(6):963-9. doi: 10.1093/ajcn/54.6.963.

  PMID: 1957828 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 17, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ES (1)