Cardiac Catheterization Clinical Trial
Official title:
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 42 Months |
Eligibility | Inclusion Criteria: - Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation. Exclusion Criteria: - Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia. - Patient has a tracheostomy. - Patient is ventilator-dependent. - Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation. - Patient is unlikely (in opinion of anesthesia team) or is unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to the size of the patient or their airway. - Patient is already intubated prior to the scheduled procedure. - It is anticipated that the patient will not be extubated after the catheterization procedure. - Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards. - Allergy to plastic/materials in USD-ETT |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
John R. Charpie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of the USD-ETTs visualized by ultrasound | Reported as a 'yes' or 'no' - this outcome simply seeks to verify if the ultrasound can detect the ultrasound detectable cuffed endotracheal tube. The outcome measure assesses if the device is detectable as designed. It does not assess health related information. | Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation | |
Secondary | Adverse events that could be related to the USD-ETT device | Up to 30 days post intubation | ||
Secondary | Safely support ventilation and oxygenation of the patient during the procedure | Assessed by the question: "Were there any desaturation events, inability to property ventilate the patient or, blood gas abnormalities, that could be attributable to the ETT?" will be described | Immediately following extubation | |
Secondary | Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy | Ultrasound location data compared to fluoroscopy location data using a weighted Kappa statistic | Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05539092 -
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients
|
N/A | |
Completed |
NCT02074527 -
CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography
|
||
Completed |
NCT01157338 -
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
|
N/A | |
Terminated |
NCT00850473 -
PET/CT Study in the Diagnosis of Coronary Plaque
|
N/A | |
Completed |
NCT03645837 -
Rapid Clamp Release Post Trans-radial Cardiac Catheterization
|
N/A | |
Completed |
NCT04404257 -
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
|
N/A | |
Recruiting |
NCT03555500 -
Fasting or Non Fasting for Cardiac Catheterization
|
N/A | |
Not yet recruiting |
NCT06134141 -
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital
|
||
Recruiting |
NCT05632640 -
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
|
N/A | |
Unknown status |
NCT00838175 -
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
|
N/A | |
Completed |
NCT03243942 -
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
|
Phase 2 | |
Completed |
NCT01155167 -
Topical Radial Artery Vasodilation
|
Phase 2/Phase 3 | |
Completed |
NCT04258007 -
Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization
|
N/A | |
Withdrawn |
NCT00825331 -
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
|
N/A | |
Recruiting |
NCT05225077 -
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
|
Phase 4 | |
Completed |
NCT05117359 -
Transcatheter Para-Valvular Leak Closures
|
||
Recruiting |
NCT00849940 -
Validation of Brain Oxygenation Monitor on Pediatric Patients
|
N/A | |
Active, not recruiting |
NCT05364463 -
Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation (RadialHUS)
|
N/A | |
Completed |
NCT03245255 -
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
|
Phase 2 | |
Enrolling by invitation |
NCT05628779 -
Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation
|
N/A |