Clinical Research Directory

The Effects of Nocturnal Non-invasive Ventilation in Stable COPD

Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes. However, the mechanism behind these improvements are unknown. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair pathways in patients with COPD. In the present study we aim to investigate, in COPD patients with CHRF, 1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as compared to standard care 2. the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology. 3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: multicentre randomised controlled study investigating the effects of NIV on airway morphology, airway inflammation and remodelling in hypercapnic COPD patients including a control group that will postpone the initiation of NIV for 3 months. In addition we will investigate how patient demographics, patient and disease characteristics and systemic and airway inflammation predict the response to chronic NIV in severe stable COPD. To do this, all patients will be followed for 6 months after NIV initiation. Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months.

Custom Non-invasive Ventilation Masks in Children

One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.

HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport

The HERMES Phase I-II study was a two-phase observational investigation designed to characterize contemporary practices and safety-related challenges associated with the transport of patients requiring advanced respiratory support and to assess the operational feasibility of portable external electrical power during ambulance transport. Phase I consisted of an international electronic cross-sectional survey of healthcare professionals involved in noninvasive ventilation (NIV) management or patient transport. The survey evaluated reported transport indications, ventilator type and positioning, respiratory interfaces, transport-team composition, and perceived patient-, equipment-, and environment-related problems. Phase II was a prospective descriptive feasibility evaluation involving 25 ambulance transports performed in Albacete and Bilbao, Spain. Patients were transported while receiving high-flow nasal oxygen (HFNO), rescue NIV, or invasive mechanical ventilation. A portable external power supply was used to support continuity of powered respiratory-support equipment during transport. The primary technical feasibility outcome was successful completion of transport while maintaining respiratory support without reported power interruption, clinically relevant equipment alarm, or technical failure. The two phases were analyzed independently and were intended to characterize respiratory-support transport practices and evaluate technical and operational feasibility rather than establish comparative effectiveness, clinical superiority, or prevention of clinical deterioration.

HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport

The HERMES Phase III study is an international, multicenter, prospective observational investigation designed to characterize the quality and safety of patient transport during advanced respiratory support. The study will enroll patients undergoing prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support, including high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation, as determined by routine clinical practice. The study protocol will not assign respiratory-support modalities, transport strategies, or therapeutic interventions. The primary objective is to prospectively evaluate clinical, technical, organizational, and transport-related factors associated with the safe continuation of respiratory support throughout patient transport. Data collection will include patient characteristics, respiratory-support modality and settings, transport characteristics, physiologic monitoring, transport-team composition, oxygen and electrical power resources, equipment-related events, interruptions or modifications of respiratory support, clinical deterioration, rescue interventions, escalation of respiratory support, and other transport-associated adverse events. HERMES Phase III constitutes the prospective multicenter component of a broader research program that previously included an international survey of respiratory-support transport practices and an exploratory prospective feasibility evaluation of portable external power during ambulance transport.

RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV

This is a multicenter prospective cohort study designed to develop and validate a multisensor-based real-time monitoring and intelligent early warning model for acute exacerbations in patients with chronic obstructive pulmonary disease receiving home noninvasive positive pressure ventilation. Eligible participants will be adults with severe COPD and chronic hypercapnic respiratory failure who are receiving or newly initiating home noninvasive positive pressure ventilation. Participants will undergo baseline assessment and follow-up visits at 3, 6, and 12 months. Clinical data, arterial blood gas measurements, pulmonary function, exercise capacity, symptom burden, health-related quality of life, psychological status, home noninvasive ventilation parameters, adherence, device-related adverse events, healthcare utilization, acute exacerbations, hospitalizations, intensive care unit admissions, invasive mechanical ventilation, and mortality will be collected. Continuous physiological monitoring data, will be used to construct individualized stable baseline values and to identify digital warning signals. Digital warning events will be further adjudicated through symptom confirmation, treatment and healthcare utilization verification, exclusion of alternative explanations, and investigator assessment. The study aims to establish a longitudinal clinical and physiological dataset for COPD patients receiving home noninvasive ventilation and to evaluate the performance of a multisensor-based early warning model for clinically confirmed acute exacerbations of COPD.

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.

Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients

The aim of this clinical trial is to find out whether a synchrony-optimized education program for non-invasive ventilation (NIV) can help ICU patients use their ventilator more effectively and improve their comfort, symptoms, and psychological well-being. Researchers want to answer these main questions: Can a structured two-session NIV education program help patients use their ventilator more regularly and for longer periods? Does this type of training reduce anxiety, depression, and respiratory symptoms? Can synchrony training improve patients' comfort and reduce NIV-related problems such as mask leaks or sleep disturbances? Is this program more effective than the routine ICU education normally provided? What Will Happen in the Study Adults (18+) who are receiving NIV in the ICU will participate in this study. Participants will be randomly assigned to one of two groups: Intervention Group: Will receive the SYNC-NIV education program, consisting of: One hands-on session (20-40 minutes) teaching patients how to synchronize their breathing with the ventilator One supplementary session (45-60 minutes) covering mask management, preventing complications, reducing leaks, breathing exercises, equipment care, and alarm handling An educational booklet for continued support Control Group: Will receive the standard ICU education normally provided about the ICU environment, general care, communication, and monitoring. All participants will be evaluated at three times: before the intervention, the day after the program ends, and one week later.

Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score

Difficult facemask ventilation remains poorly classified. Existing definitions rely on expert opinion and subjective rating of surrogates. This lack of standardization has led to highly variable reported incidences and inconsistencies in clinical practice and research. This secondary analysis of the prospective observational MASCAN study aims to develop and validate a data-driven objective classification system for difficult facemask ventilation and to determine its diagnostic performance and calibration. Facemask ventilation was facilitated after anaesthesia induction in all patients. An independent observer systematically assessed potential indicators for difficult facemask ventilation that serve as candidate predictor variables for the fitting of a diagnostic multivariable logistic regression model and simplified score to classify difficult facemask ventilation. Cross-validated LASSO regression will be used for variable selection. The area under the receiver operating characteristic curve (AUROC) and calibration curves will be used to quantify the diagnostic performance and calibration, and optimal decision thresholds will be defined.

Comparison of the Silverman-Andersen Score and the Downes Score

This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as well as to evaluate the agreement of these scoring systems with other methods used to assess the severity of respiratory distress. The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.

Epidemiology of Non- Invasive Mechanical Ventilation in Argentina: a Multicenter Observational Study

Introduction Non-invasive mechanical ventilation (NIMV) is a fundamental strategy in the management of acute respiratory failure, preventing intubation and reducing complications. However, the epidemiology of its use in Argentina is not well understood, motivating this study. Justification Unequal access to ICU resources in Argentina affects the quality of care. This study aims to describe the implementation, effectiveness, and outcomes of NIMV across different regions of the country to improve clinical decision-making and healthcare policies. Objectives * Primary: Analyze the survival of ICU patients receiving NIMV. * Secondary: Evaluate success/failure factors, regional disparities in resource availability, the impact of healthcare staff training, comparison between public and private sectors, and establish a national database. Methods Study Design Observational, multicenter, prospective, and analytical study. Both public and private hospitals in Argentina will be included. Data will be collected over seven months, with patient follow-up until discharge or death. Study Population Adult patients (\>18 years) admitted to the ICU requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation. Inclusion Criteria * Age \>18 years. * Use of NIMV in the ICU for respiratory failure or during weaning. * Signed informed consent. Exclusion Criteria * Patients using home NIMV without exacerbation. * Patients without acute respiratory impairment. Data Collection and Management * Data will be recorded using an electronic form in RedCap®, with restricted access. * Confidentiality will be ensured through alphanumeric coding. * A monitoring committee will supervise data quality. Statistical Analysis * Continuous variables: Mean and standard deviation or median and interquartile range. * Comparisons: Student's t-test, Mann-Whitney U test, Chi² test, or Fisher's exact test. * Multivariate models: Logistic regression and Kaplan-Meier survival analysis. Bias Control and Data Quality Strategies will be implemented to minimize selection, information, and investigator bias. Data will be periodically reviewed by the monitoring committee. Study Feasibility The study is supported by the British Hospital of Buenos Aires and the Argentine Society of Intensive Care Medicine, ensuring its viability. Ethical Considerations The study will comply with national and international health research regulations, ensuring participant confidentiality. Publication and Funding The study will be funded by the Argentine Society of Intensive Care Medicine, with no external financial support. Authorship in publications will depend on the number of patients included per center. Conclusion This study aims to generate key information on NIMV use in Argentina, optimizing its application and improving ICU care nationwide.

Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intubation-free Survival in Acute Hypoxemic Respiratory Failure: the TRIPOD Randomized Clinical Trial

Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.

Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure

This is a single center, retrospective, propensity score matching cohort study that explores the efficacy and safety of high flow nasal cannula and non-invasive ventilation in the treatment of acute respiratory failure associated with pulmonary arterial hypertension, stratified by the severity of right ventricular dysfunction. The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV). Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality. This study addresses whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation. This study is of great significance as it is based on a patient stratification method of right ventricular dysfunction severity to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.

Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection

Prospective, observational multicentric study which aims at identifying lung POCUS (Point of Care UltraSound) findings associated with failure of noninvasive ICU-LRS (Intensive Care Unit Level Respiratory Support) (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI (Low Respiratory Tract Infection) and at identifying lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.