Aortic Stenosis
Conditions
Brief summary
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
Interventions
PROCEDUREGeneral Anesthesia
General anesthesia by standard endotracheal intubation.
PROCEDUREConscious Sedation
Conscious sedation
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation) 2. Age over 18 years of age. 3. Women of child bearing age must have a negative urine or serum pregnancy test. 4. Clinical indication for a transfemoral aortic valve replacement. 5. English or Spanish speaking 6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.
Exclusion criteria
1. BMI \> 40 2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr. 3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc). 4. Inability to lie supine for more than 30 minutes. 5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access. 6. Patient refusal 7. Patient involved in another research study 8. Psychiatric condition precluding ability to provide informed consent 9. History of clinical stroke within 3 months prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-on-table | <1 day | * time to patient on table to surgical drapes down * time to patient on table to when deemed safe for transport by anesthesiologist and surgeon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with serious adverse events | within 30 days | * deaths * conversion from sedation to intubation * hypersensitivity reactions |
| Length of stay | within 30 days | * ICU length of stay (days) * Hospital length of stay (days) |
| Readmissions | within 30 days | Number of patients readmitted within 30 days of initial procedure |
| Contrast usage | <1 day | Amount of contrast used in mL for procedure |
| Fluoroscopy time | <1 day | Amount of time fluoroscopy used |
| Number of Patients with Valve Complications | within 30 days | * paravalvular leak on echocardiogram * pacemaker requirement * vascular complications requiring reintervention * post-procedure requiring valve dilation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-procedure Complications | within 30 days | * TIA or Stroke * Myocardial Infarction * Bleeding * Infection |
| Quality of Life | Procedure start to 30 days | Kansas City Cardiomyopathy Questionnaire at 30 days |
Outcome results
None listed