Cardiac Disease
Conditions
Keywords
Cardiac Surgery
Brief 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.
Detailed description
At the induction of anesthesia, Participants will be breathing 100% oxygen via a face mask and then, become anesthetized according to a standard protocol and at the discretion of the attending anesthesiologist. Participants will be receive fentanyl, lidocaine and either succinylcholine or vecuronium to facilitate tracheal intubation. Laryngoscopy will then be performed and the trachea intubated with a standard cuffed ETT. Inflation of the ETT cuff will be performed in accordance with the randomization of either air or 1.8% lidocaine/0.76% solution until such time as there is no air leak around the tube when administering positive pressure to 20 cm H2O. Anesthesia will be maintained with volatile anesthetic with or without a Propofol infusion. Vecuronium will be used to maintain the ulnar nerve train-of-four at 0-3 of four twitches. Lungs will be mechanically ventilated with tidal volumes of 6-8 mL/kg to maintain end-tidalCO2 concentration at 30-35 mm Hg. Anesthesia maintenance will occur until the near end of the surgical procedure. The volatile anesthetic will be discontinued and Propofol will be initiated via a continuous infusion to facilitate transportation to the intensive care unit (ICU). After arrival to the ICU, Neuromuscular blockade will then be antagonized with neostigmine and glycopyrrolate, and the pharynx being gently suctioned under direct vision. Mechanical ventilation to be maintained until swallowing or spontaneous respiration begins, and then, converted to assisted manual ventilation. Extubation will be performed when all of the following criteria are met: 1) full reversal of neuromuscular block (ulnar nerve T4/T1 ratio 1:1, with sustained tetanus at 50 Hz for 5 s and no fade); 2) spontaneous ventilation; and 3) the ability to follow verbal commands (eye opening or hand grip) or demonstrate purposeful unilateral movement (attempting self-extubation); 4) demonstration of hemodynamic stability; 5) adequate hemostasis with combined chest tube output \< 100 ml/hour. The Participant then will be closely monitored as a 1:1 by the room nurse, and by other staff (respiratory therapist, and ICU fellows and consultants) for toleration of the ventilator (coughing, double triggering, bucking, etc.). on the cardiac surgical intensive care unit. Sedation amount will be recorded electronically once the patient lands in the ICU, until the time of extubation. A member from the study team will physically record yes, or no, on the form provided regarding the patient coughing, complaining of a sore throat or difficulty swallowing, having hoarseness or difficulty speaking.
Interventions
At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water. This solution will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
Sponsors
Study design
Eligibility
Inclusion 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 \< 18 years old at time of surgery * Patients who are not sent to the cardiac ICU post-operatively * Patients who are anticipated to have a difficult tracheal intubation * Patients having risk factors of postoperative aspiration of gastric contents * Patients who have respiratory disease or recent respiratory tract infection * \> 1 attempt to secure an airway * Patients undergoing transcatheter aortic valve replacement (TAVR) procedures or any form of robotic procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sedation Requirements | baseline through extubation | Total amount of Propofol dose used as measured in total milligrams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Mechanical Ventilation | baseline through extubation | Total amount of time that the participant is intubated as measured in minutes. |
| Richmond Agitation-Sedation Score (RASS) | 4 hours post-extubation | The Richmond Agitation-Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient.. It is a 10-point scale comprised of four levels of agitation (+1 to +4), one level defining a calm and alert state (0) and five levels of sedation (-1 to -5). The higher the positive number (+) the more agitated or combative a patient is and the higher the negative number (-) the deeper the sedation of the patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buffered Lidocaine 1.8% lidocaine plus 0.76% sodium bicarbonate: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water | 14 |
| Air Only Air: At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation. | 18 |
| Total | 32 |
Baseline characteristics
| Characteristic | Air Only | Total | Buffered Lidocaine |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 16.6 | 60.7 years STANDARD_DEVIATION 15.8 | 62.1 years STANDARD_DEVIATION 14.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 18 participants | 32 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 18 |
| other Total, other adverse events | 14 / 14 | 18 / 18 |
| serious Total, serious adverse events | 0 / 14 | 0 / 18 |
Outcome results
Total Sedation Requirements
Total amount of Propofol dose used as measured in total milligrams.
Time frame: baseline through extubation
Population: Only 10 subjects in the buffered lidocaine arm and 13 subjects in the air only arm received Propofol for sedation. The remaining subjects received other sedation drugs per physician discretion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered Lidocaine | Total Sedation Requirements | 325 milligrams | Standard Deviation 248 |
| Air Only | Total Sedation Requirements | 1158 milligrams | Standard Deviation 1426 |
Richmond Agitation-Sedation Score (RASS)
The Richmond Agitation-Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient.. It is a 10-point scale comprised of four levels of agitation (+1 to +4), one level defining a calm and alert state (0) and five levels of sedation (-1 to -5). The higher the positive number (+) the more agitated or combative a patient is and the higher the negative number (-) the deeper the sedation of the patient.
Time frame: 4 hours post-extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered Lidocaine | Richmond Agitation-Sedation Score (RASS) | -0.2 score on a scale | Standard Deviation 0.4 |
| Air Only | Richmond Agitation-Sedation Score (RASS) | -0.4 score on a scale | Standard Deviation 0.5 |
Total Duration of Mechanical Ventilation
Total amount of time that the participant is intubated as measured in minutes.
Time frame: baseline through extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Buffered Lidocaine | Total Duration of Mechanical Ventilation | 499 minutes |
| Air Only | Total Duration of Mechanical Ventilation | 529 minutes |