Clinical trials: Respiratory, Diaphragm
ARDS (Moderate or Severe), AHRF
STimulation to Activate RespIration
Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute…
- Conditions
- ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients
- Trial name
- STARI (NCT06832306)
- Testing
- Phrenic Nerve Stimulation
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Lungpacer Medical Inc.
Respiration, Artificial
Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion
Justification: The diaphragm is the main inspiratory muscle. Its dysfunction therefore compromises ventilation, which is necessary for gas exchange. Diaphragmatic dysfunction is frequently observed in resuscitation patients.
- Trial name
- WEAN-US (NCT04008875)
- Where
- 3 sites in France
- Volunteers
- 39 people
- Sponsor
- Respinor AS
Ventilator-induced Diaphragm Dysfunction, VIDD
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs.
- Conditions
- Ventilator-induced Diaphragm Dysfunction, VIDD, Weaning Failure
- Trial name
- NCT07363902
- Testing
- Heecap
- Where
- 3 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Tesai Care SL
Mechanical Ventilation
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
- Trial name
- NCT01868685
- Testing
- BYM338
- Sponsor
- Novartis Pharmaceuticals
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and…
- Trial name
- RESCUE1 (NCT03107949)
- Testing
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator-Induced Lung Injury
Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
- Trial name
- NCT03659552
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator Induced Diaphragm Dysfunction
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned.
- Trial name
- AERO-PAS (NCT07477054)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Lungpacer Medical Inc.
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical
Ventilator-Induced Diaphragm Dysfunction
Study of TransAeris® System for Enhanced Recovery After Surgery in France
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT05404477)
- Testing
- TransAeris System
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Diaphragm Issues
STIMIT Activator 1 IDE Study
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been…
- Trial name
- NCT05883163
- Testing
- Stimit Activator 1
- Where
- 4 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Stimit AG
Singing, Breathing Exercise
The Effect of Osteopathy and Complete Vocal Technique on Phonation in Amateur Singers
This study is about breathing function during singing, specifically aimed at improving the functionof the muscles in the respiratory system involved in control over the voice.The goal of the study is to examine if osteopathic…
- Conditions
- Singing, Breathing Exercise, Osteopathy
- Trial name
- NCT07007845
- Testing
- CVT Support intervention, Dooming Diaphragm
- Where
- Denmark
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Complete Vocal Institute
Ventilation Therapy; Complications
Diaphragmatic Mobility In Ventilated Assisted Patients
The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients…
- Trial name
- NCT04733261
- Testing
- Diaphragmatic mobility, Chest Physiotherapy
- Where
- Pakistan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aqua Medical Services (Pvt) Ltd
Respiratory Failure
Multicenter, Multinational, Follow-Up Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
The study will be a multicenter, multinational, prospective single arm blinded non-interventional follow-up study (from DXT-CS-005) to validate RESPINOR DXT's performance to identify patients at increased risk of weaning failure…
- Trial name
- DE-RISK WF II (NCT05580185)
- Testing
- RESPINOR DXT
- Where
- 8 sites in France, Norway
- Volunteers
- 145 people
- Sponsor
- Respinor AS
Respiration, Artificial
Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body.
- Trial name
- NCT03896048
- Where
- Norway
- Volunteers
- 11 people
- Sponsor
- Respinor AS
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts.
- Trial name
- RESCUE2 (NCT03096639)
- Testing
- Diaphragmatic Pacing Therapy DPTS
- Where
- 21 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- Lungpacer Medical Inc.
Contraception
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
- Trial name
- NCT00397670
- Testing
- Drug: BufferGel® with diaphragm
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- ReProtect Inc
Atrial Fibrillation
First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation
The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation.
- Trial name
- SAFE-CMAP (NCT07820631)
- Testing
- Circle Safe System Use During Pulmonary Vein Ablation
- Where
- 4 sites in France, New Zealand
- Volunteers
- 50 people
- Sponsor
- Circle Safe, Inc.
Ventilator-Induced Diaphragm Dysfunction
Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged…
- Trial name
- TRANSITION (NCT04309123)
- Testing
- TransAeris System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Amyotrophic Lateral Sclerosis
NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
- Trial name
- PARADIGM (NCT03034317)
- Testing
- NeuRx DPS
- Sponsor
- Synapse Biomedical
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.