Clinical trials: Non-Invasive Ventilation
COPD, Hypercapnic Respiratory Failure
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without…
- Trial name
- NCT01987661
- Testing
- BIPAP ST, Airtrap
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV
Healthy
Non Invasive Ventilation Comfort Study
Patients who are suffering from a variety of respiratory conditions benefit from continuous positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV).
- Trial name
- NCT02473068
- Testing
- CPAP
- Where
- New Zealand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Distress Syndrome (RDS)
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP)…
- Trial name
- LISPAP (NCT02772081)
- Testing
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Where
- 26 sites in United States
- Volunteers
- 33 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Failure, Neuromuscular Disease
Ventilator Monitoring in Early Exacerbation Detection
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing)…
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease
- Trial name
- NCT01644162
- Testing
- iVAPS ventilation
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- ResMed
Chronic Obstructive Pulmonary Disease
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging…
- Trial name
- NCT01592656
- Testing
- Functional Respiratory Imaging, Lung compliance measurement, Non-invasive ventilation (Respironics)
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- FLUIDDA nv
Respiratory Failure
Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
- Trial name
- NCT05479773
- Testing
- Standard NIV mask, Lumena NIV mask
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Inspir Labs Ltd.
Healthy Volunteers, Noninvasive Ventilation
The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy.
- Trial name
- NCT06670482
- Testing
- Non-invasive ventilation (NIV)
- Where
- New Zealand
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea
Validation of a Wearable Non-invasive Device (the Patch)
BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.
- Trial name
- NCT03816566
- Testing
- patch
- Where
- 2 sites in Canada
- Volunteers
- 60 people
- Sponsor
- BresoTEC Inc.
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Nocturnal Hypoventilation, Neuromuscular Disease
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal…
- Conditions
- Nocturnal Hypoventilation, Neuromuscular Disease, Chest Wall Disorder
- Trial name
- NCT00901485
- Testing
- AutoVPAP, VPAPIIIST-A
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- ResMed
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Healthy Volunteers
The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy.
- Trial name
- NCT07463716
- Testing
- Non-invasive ventilation (NIV)
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome (OHS)
Evaluation of Auto-EPAP for Management of Upper Airway Obstruction During Non-Invasive Ventilation
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
- Conditions
- Obstructive Sleep Apnea, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Diseases (NMD)
- Trial name
- Vivo NOVA (NCT06560411)
- Testing
- Non-Invasive Ventilation
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Breas Medical, Inc.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Assessment of Breathing Pattern During NIV
COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these…
- Trial name
- NCT06682286
- Testing
- NIV mask A, NIV mask B
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Failure
Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation
This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive…
- Trial name
- PUPPVMNI (NCT02526862)
- Testing
- Allevyn Thin®, Askina Transorbent Border®, Linovera®
- Where
- Spain
- Volunteers
- 152 people
- Sponsor
- B. Braun Medical SA
Respiratory Monitoring
Comparison of Non-Invasive Respiratory Monitoring System (RMS)
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (manual counting) in healthy human subjects.
- Trial name
- NCT06000852
- Testing
- Makani Science Respiratory Monitoring System
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Michael Chu
Elective Procedures Requiring Mechanical Ventilation
Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine
This is a prospective, observational study to assess agreement of pulmonary health parameters measured by a new non-invasive physiologic monitor, the VQm pulmonary health monitor (PHM)™ with clinical gold standards.
- Trial name
- NCT04730063
- Testing
- VQm PHM™
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Rostrum Medical Innovations Inc.
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