Clinical Research Directory

The Feasibility of Electrical Impedance Tomography to Guide Non-invasive Respiratory Interventions in Chronic Respiratory Disease

This study aims to use Electrical Impedance Tomography (EIT) to optimise breathing machines for people with problems with their breathing. This might improve their ability to use their breathing machine. By providing real-time pictures of the lungs, EIT can help clinicians tailor breathing machine settings to meet each persons needs. Long term respiratory failure is a serious condition that causes extreme difficulty breathing. There are a lot of people in the UK with respiratory failure. It costs the NHS a lot of money to support these people. People with long term respiratory failure often spend a lot of time in hospital. Non-invasive ventilation (NIV) is a key treatment for these patients. NIV is a breathing machine that supports breathing and helps get rid of waste gases (including carbon dioxide) from the lungs. Cough assist helps people to cough and clear secretion. Lots of patients find using breathing machine hard. It can be difficult to set the machines up to suit each persons needs. Electrical Impedance Tomography (EIT) is a promising technology that provides real-time pictures of the lungs without radiation exposure. A chest belt sends painless, harmless low-level electrical currents through the lungs. This creates an instant picture of the lungs. EIT has shown to be useful in critical care settings to optimise breathing machine settings. EIT in respiratory failure has not been tested. Project Goal: Assess if Electrical Impedance Tomography (EIT) can make breathing machine settings better for people with respiratory failure. Objectives: Work package 1 * Use EIT to look at and adjust settings on breathing machines (NIV). * Check if adjustments using EIT help patients use their breathing machines more often. * Ask people if they feel any better with the machine on the new settings * Ask people about changes in their symptoms after the changes on the machines have been made Work package 2 * Use EIT to observe lung air movement during mechanical insufflation-exsufflation (MI:E). Project Structure Recruitment: We aim to have 20 participants from the Royal Free Hospital. We aim to have 5-10 participants in each part of the study. Baseline Measurements: Work package 1 Body metrics, current NIV therapy, transcutaneous CO2 (TcCO2), spirometry, and forced oscillation technique (FOT), capillary blood gas(CBG). Work package 2 Spirometry, sniff nasal inspiratory pressure (SNIP), and peak cough flow, capillary blood gas. Interventions: Work package 1 Use EIT to improve settings on the breathing machine. Patients will wear the EIT belt to get a baseline. Expert clinicians will change breathing machine settings whilst looking at the EIT pictures. New and improved settings will be tested for 2-4 hours. Patients will then be sent home on these new settings and tests will be redone after one month on the new and improved settings. Work package 2 Use EIT to monitor the effects of MI:E. Participants will undergo five short MI:E sessions of 1-2minutes with a 20minute rest between sessions, with EIT attached, adjusting pressures by 20%. EIT will track the changes in how air moves within the lungs during different MI:E prescriptions. Data Analysis: We will compare the tests as baseline and one month follow-up using statistics. The statistical tests will help us work out if using EIT to guide the NIV and M I:E machine settings makes them better for patients.

Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Stress balls have been widely used as a distraction technique to reduce pain, anxiety, and stress by redirecting attention and promoting endorphin release. Although previous nursing studies have demonstrated their benefits in various clinical settings, evidence regarding their use in patients receiving Non-invasive mechanical ventilation is limited. To date, only one study has evaluated stress ball use in patients with chronic obstructive pulmonary disease receiving Non-invasive mechanical ventilation, focusing on pain and anxiety without assessing treatment duration or mask adherence. This study aims to evaluate the effects of stress ball use on treatment duration, anxiety, and mask adherence in patients receiving Non-invasive mechanical ventilation.

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

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.

Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital

This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD

Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and diaphragmatic thickening between spontaneous breathing and non-invasive ventilation ? Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.

Value of Volume Oxygenation Index to Detect Early Failure of Non-invasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Non-invasive ventilation (NIV) is an evidence-based treatment for patients with acute respiratory failure due to an exacerbation of Chronic Obstructive Pulmonary Disease (COPD). In patients with COPD and acute hypercapnic respiratory failure, NIV improves gas exchange, reduces the work of breathing, and decreases the length of hospital stay and mortality \[1\]. Furthermore, when compared to invasive ventilation, NIV leads to fewer complications, such as ventilator-related infections \[2\]. These findings have resulted in guideline recommendations for the use of NIV in acute respiratory failure due to an exacerbation of COPD \[3\].NIV failure has been defined as the need for endotracheal intubation (ETI) or death. Its rate varies greatly between 5% and 60%, depending on numerous factors \[4\]. The Volume Oxygenation (VOX) index, initially developed to predict treatment failure of high flow nasal cannula therapy, has demonstrated the ability to estimate early increases in respiratory drive. Within the first 2 h, the VOX index exhibits a discriminative potential of 0.88 (95 % CI 0.79-0.97) in predicting HFNC failure \[5\]. Based on this premise, we hypothesize that the VOX index could be a predictive tool for NIV treatment failure.

Music Therapy During NIV Implantation in Pediatric Intensive Care Units

Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique. The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children. To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation. The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).