Clinical trials: Non Invasive Ventilation (NIV)
Respiratory Insufficiency Requiring Mechanical Ventilation
Registry for Automated Mechanical VEntilation in Adults
The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients…
- Trial name
- RAVE (NCT06655805)
- Testing
- Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
- Where
- 4 sites in Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Hamilton Medical AG
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy
- Conditions
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
- Trial name
- NCT02726048
- Testing
- Simplus/Eson
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
Quality of Life
Consequences of Respiratory Devices on Caregivers (CAP2)
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.
- Trial name
- CAP2 (NCT04632836)
- Testing
- quality of life questionnaires
- Where
- France
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Asten Sante
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
The purpose of this study is to evaluate the effectiveness and clinical efficiency of combining home non-invasive ventilation (NIV) with a continuous remote telemonitoring (TM) system in patients with Chronic Obstructive…
- Trial name
- EVALECO (NCT07679646)
- Testing
- Home Non-Invasive Ventilation and Telemonitoring
- Where
- Spain
- Volunteers
- 92 people
- Sponsor
- Air Liquide Healthcare Spain
Non-Invasive Ventilation
Wearable Noninvasive Positive Pressure Ventilation Device in COPD
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
- Trial name
- VITABREATH (NCT03130361)
- Testing
- Non-Invasive Ventilation
- Where
- 7 sites in France
- Volunteers
- 40 people
- Sponsor
- Icadom
Sleep-disordered Breathing, Hypercapnia
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support.
- Trial name
- NCT04926805
- Testing
- CPAP with Mask A, CPAP with Mask B
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Insufficiency, Respiratory Failure
Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.
Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with…
- Trial name
- NCT07484802
- Testing
- NIV interface with airway washout
- Volunteers
- 60 people
- Sponsor
- Fisher and Paykel Healthcare
Focus of the Study is the Anatomy of the Soft Palate, Non-invasive Ventilation
The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers.
- Trial name
- NCT06738589
- Testing
- non-invasive ventilation
- Where
- New Zealand
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Failure, Neuromuscular Disease
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease
- Trial name
- NCT01174316
- Testing
- AutoVPAP™, VPAPIIIST-A™
- Where
- United Kingdom
- Sponsor
- ResMed
Chronic Obstructive Pulmonary Disease
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on: the amount of daily physical activity Quality of life The 6-minute walk distance Time to…
- Trial name
- NCT02100709
- Testing
- BiLevel Noninvasive Ventilation
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- ResMed
Chronic Obstructive Pulmonary Disease
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic…
- Trial name
- ECHO/ICU (NCT01155310)
- Testing
- Helium/Oxygen 78%/22%, Air/Oxygen
- Where
- 16 sites in Belgium, France and 4 more
- Volunteers
- 446 people
- Sponsor
- Air Liquide Santé International
COPD
Vector Engineering Clinical
This study aimed to validate a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation (EFL).
- Trial name
- NCT04725500
- Testing
- Auto-Titrating EPAP
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Obesity-Hypoventilation Syndrome (OHS)
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings.
- Trial name
- NIV-OHS (NCT00603096)
- Testing
- GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Tyco Healthcare Group
Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and…
- Trial name
- NCT06007495
- Testing
- Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb, Conventional full-face mask - dual-limb
- Where
- 2 sites in Canada
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Overlap Syndrome
Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome
The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start…
- Trial name
- OVNI-Dom (NCT02363413)
- Testing
- IniVAH, IniVAD
- Where
- 17 sites in France
- Volunteers
- 80 people
- Sponsor
- IP Santé Domicile
Chronic Respiratory Failure With Hypercapnia, Chronic Obstructive Pulmonary Disease (COPD)
Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years.
- Conditions
- Chronic Respiratory Failure With Hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS)
- Trial name
- e-VENT (NCT04615078)
- Testing
- ETAPES Program
- Where
- 11 sites in France
- Volunteers
- 56 people
- Sponsor
- Air Liquide Santé International
Noninvasive Ventilation, Respiratory Insufficiency
A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask
Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.
- Trial name
- mask (NCT02383719)
- Testing
- Oro-nasal Mask
- Volunteers
- 18 people
- Sponsor
- Convergent Engineering, Inc.
Noninvasive Ventilation
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure
This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure.
- Trial name
- NCT05964244
- Testing
- Vela Investigational Mask, Nivairo Standard Mask
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing.
- Trial name
- NCT06972589
- Testing
- Investigational Mask, Conventional mask
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
COPD, Chronic Hypercapnic Respiratory Failure
Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation
Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients…
- Trial name
- NCT01986413
- Testing
- pressure controlled ventilation BIPAP ST, volume assured pressure support IVAPS, NIV
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV