Phase 2
N=32
Lidocaine as an Endotracheal Tube (ETT) Cuff Media
Cardiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT03343080 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Total Sedation Requirements — 325; 1158 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1.8% lidocaine plus 0.76% sodium bicarbonate (Drug); Air (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sedation Requirements |
325; 1158 | — |
| SECONDARY Total Duration of Mechanical Ventilation |
499; 529 | 0.776 |
| SECONDARY Richmond Agitation-Sedation Score (RASS) |
-0.2; -0.4 | 0.296 |
Summary
Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air is the traditional method used to inflate the breathing tube cuff. Researchers wish to find if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for this particular surgical intervention.
Eligibility Criteria
Patients who meet the inclusion criteria below and are expected to require ventilatory support for a period of less than 5 hours post-operatively in the cardiac ICU will be enrolled.
Inclusion Criteria
- All patients > 18 years of age (male and female) who will receive general anesthesia for cardiac surgery at St. Mary's Hospital (SMH) in Rochester, Minnesota
- Cardiac surgery includes: single valve repair, myectomy, cabbage, pericardectomy.
- American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria
- Age 1 attempt to secure an airway
- Patients undergoing transcatheter aortic valve replacement (TAVR) procedures or any form of "robotic" procedures
Data sourced from ClinicalTrials.gov (NCT03343080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.