Phase 3 N=260 Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Prolonged Air Leak · Lung Resection
Primary: Number of Participants With Prolonged Air Leak (PAL) — 33; 24 Participants — p=0.171
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=444 NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Lung Cancer · Lung Tumor
Primary: Safety Endpoints — 22; 48; 25; 40 Events
N/A N=112 Progel® Pleural Air Leak Sealant (PALS) in Video and Robotic Assisted Thoracoscopic Surgery
Pulmonary Disease
Primary: Rate of Device and/or Procedure-related Adverse Events — 42.5 percentage of participants
N/A N=76 Evaluating Air Leak Detection in Intubated Patients
Critical Care
Primary: CO2 Leakage Above the ETT Cuff, Measured Over Time. — 0.09; 0.22 [CO2 mmHg*hour]/hour
N/A N=160 Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Left Atrail Appendage Closure: Peri-device Leaks
Primary: Size of PDL After Leak Closure Procedure — 0; 0; 0; 64 Participants
N/A N=50 ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Lung Cancer
Primary: Incidence of Prolonged Air Leaks — 5 participants
Phase 3 N=168 Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Pancreatic Fistula
Primary: Number of Patients With Pancreatic Fistula — 9; 8 participants
N/A N=198 Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation
Liberation From Mechanical Ventilation
Primary: Total Days of Mechanical Ventilatory Support — 6.51; 4.02 days
N/A N=40 Lung Collapse With Bronchial Blocker
Video-assisted Thoracoscopic Surgery · Lung Isolation Device · One-lung Ventilation
Primary: Time to Obtain Complete Lung Collapse — 47.8; 32.5 minutes
N/A N=24 Factors Responsible for the Effectiveness of the Lund De-airing Technique
Complication of Surgical Procedure
Primary: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery — 49; 46 Air microemboli
N/A N=84 Endotracheal Tube Intracuff Pressure and Leak
Otolaryngological Surgery
Primary: Changes in the Intracuff Pressure — 3 cmH2O
Phase 3 N=47 Evaluation of the Bio-Seal Biopsy Track Plug
Lung Cancer
Primary: Number of Participants With Absence of Pneumothoraces — 18; 18 Participants
Phase 4 N=121 PleuraSeal Post Market Study (Europe)
Lung Disease · Pulmonary Lobectomy
Primary: Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge. — 41.9; 30.5 Percentage of participants — p=0.257
N/A N=50 The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients
Hypoxia
Primary: PaO2(Partial Pressure of Oxygen in Arterial Blood) — 178.71; 198.04; 185.25; 202.54 mmHg
N/A N=37 Clamping the Double Lumen Tube
One-lung Ventilation
Primary: T50-3 — 31.87; 63.81; 33.30; 60.82 minutes
N/A N=63 Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.
Surgical Procedure, Unspecified
Primary: Change in Intracuff Pressure — -11.8; -9.5 cmH2O
N/A N=320 Intensive Alveolar Recruitment Protocol After Cardiac Surgery
Ventilator Induced Lung Injury · Cardiac Disease · Acute Lung Injury
Primary: Severity of Pulmonary Complications in the Post-operative Period — 15; 26 percentage of participants — p=0.016
Phase 3 N=454 Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Lung Biopsy
Primary: the Rate of Pneumothorax — 42; 60; 184; 168 Participants
N/A N=50 Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
Respiratory Distress Syndrome · Bronchopulmonary Dysplasia
Primary: Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants — 12.6; 6.4; 27.2; 17.1 mL — p=<0.05
N/A N=37 Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax
Pneumothorax · Tension Pneumothorax
Primary: Pleural Pressure (Ppl) Prior to Evacuation of Pleural Air — 7.44; -1.79 cmH2O
N/A N=49 Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
Lung Collapse · One-Lung Ventilation · Thoracic Surgery
Primary: Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB. — 504; 630 milliliters…
N/A N=20 Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing
Brain Ischemia · Reduction of Cerebral Air Emboli
Primary: Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery — 46; 32 gaseous cerebral microemboli — p=1.00
N/A N=80 The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
Respiratory Aspiration
Primary: Number of Participants With Dye Leakage — 3; 2 participants
N/A N=181 AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness
Asthma
Primary: Severe Exacerbations — 30.9; 23.6; 34; 36.5 Percentage subjects severe exacerbations
Phase 3 N=339 Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Pneumothorax
Primary: Incidence Rate of Treatment Success — 126; 94 participants
N/A N=20 CO2 Versus Lund De-airing Technique in Heart Surgery
Aortic Valve Disorder
Primary: Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). — 41; 118 Air Microemboli — p=<0.01
N/A N=21 Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Primary: Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping — 17 Participants
Phase 4 N=64 Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation
Mechanical Ventilation Pressure High
Primary: Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine — 0; 0 Liters per minute
N/A N=50 Pulmonary Artery Repair With Covered Stents
Pulmonary Stenosis · Pulmonary Regurgitation · Tetralogy of Fallot
Primary: Successful Repair of Conduit Disruption — 48 participants
Phase 3 N=170 Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection
Injury of Body of Pancreas
Primary: Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula — 25; 16; 3; 5 Participants