A Phase 2 interventional study of 1.8% lidocaine plus 0.76% sodium bicarbonate and Air in Cardiac Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Supportive care
Among 22 studies in Heart Diseases by Mayo Clinic — 3 open to participants now, 4 under way, none of them phase 3. Heart Diseases · Mayo Clinic.
Among the 22 studies in Heart Diseases by Mayo Clinic, this one is one of 2 that started in 2018, is one of 2 in phase 2, and was the 12th registered.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's enrollment of 32 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →3 of the 22 studies in Heart Diseases by Mayo Clinic are open now, in 2 countries. Each count lists the studies.
Of the 180 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2018.
Median enrollment 42 across the 8 interventional studies, 1,200 across the 9 observational. Of the 16 that completed or were terminated, 2 (13%) have results posted.
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
2 of the studies in Heart Diseases by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06891222Mayo ClinicA Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening | 2026-11 |
| NCT03049254Mayo ClinicMayo AVC Registry and Biobank | 2027-03 |
Among the 22 studies in Heart Diseases by Mayo Clinic, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At the induction of anesthesia, patients 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. For cardiac surgery patients randomized to the buffered lidocaine arm, the operating room registered respiratory therapist (OR RRT) will inflate the endotracheal tube cuffs with the study drug containing 1.8% lidocaine plus 0.76% sodium bicarbonate until abatement of the air leak at 20 cm of water. The intervention will take place while in the operating room. The room nurse anesthetist (CRNA) or anesthesiologist will be aware of the amount of solution instilled in the ETT cuff. The patient will remain intubated after the surgery is complete and will be taken to the cardiac surgical ICU.
Drug: 1.8% lidocaine plus 0.76% sodium bicarbonate
At the induction of anesthesia, patients 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. For cardiac surgery patients randomized to the air arm, the operating room registered respiratory therapist (OR RRT) will inflate the endotracheal tube cuffs with air until abatement of the air leak at 20 cm of water. The intervention will take place while in the operating room. The room nurse anesthetist (CRNA) or anesthesiologist will be aware of the amount of air in the ETT cuff. The patient will remain intubated after the surgery is complete and will be taken to the cardiac surgical ICU.
Other: Air
Drug pages: Lidocaine · 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. 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.
Total Sedation Requirements
Total amount of Propofol dose used as measured in total milligrams.
Time frame: baseline through extubation
Total Duration of Mechanical Ventilation
Total amount of time that the participant is intubated as measured in minutes.
Time frame: baseline through extubation
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
| Milestone | Buffered Lidocaine | Air Only |
|---|---|---|
| Started | 14 | 18 |
| Completed | 14 | 18 |
| Not completed | 0 | 0 |
Total amount of Propofol dose used as measured in total milligrams.
| milligrams | Buffered Lidocaine | Air Only |
|---|---|---|
| Total Sedation Requirements | 325 ± 248 | 1158 ± 1426 |
Total amount of time that the participant is intubated as measured in minutes.
| minutes | Buffered Lidocaine | Air Only |
|---|---|---|
| Total Duration of Mechanical Ventilation | 499 (440 to 613) | 529 (380 to 700) |
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.
| score on a scale | Buffered Lidocaine | Air Only |
|---|---|---|
| Richmond Agitation-Sedation Score (RASS) | -0.2 ± 0.4 | -0.4 ± 0.5 |
Collected over Adverse events were recorded from baseline to 4 hours post extubation for each subject.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buffered Lidocaine | 0/14 (0%) | 0/14 (0%) | 14/14 (100%) |
| Air Only | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Event | Buffered Lidocaine | Air Only |
|---|---|---|
| Hoarseness presentGeneral disorders | 10/14 | 15/18 |
| CoughGeneral disorders | 4/14 | 7/18 |
| Difficulty swallowingGeneral disorders | 1/14 | 2/18 |
| Agitation or restlessnessGeneral disorders | 0/14 | 1/18 |
| Age, Continuous(years) | Buffered Lidocaine | Air Only | Total |
|---|---|---|---|
| Mean | 62.1 ± 14.9 | 59.4 ± 16.6 | 60.7 ± 15.8 |
| Sex: Female, Male(Participants) | Buffered Lidocaine | Air Only | Total |
|---|---|---|---|
| Female | 3 | 7 | 10 |
| Male | 11 | 11 | 22 |
| Race and Ethnicity Not Collected(Participants) | Buffered Lidocaine | Air Only | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Buffered Lidocaine | Air Only | Total |
|---|---|---|---|
| United States | 14 | 18 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Sodium Bicarbonate