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Lidocaine as an Endotracheal Tube (ETT) Cuff Media

Lidocaine as an ETT Cuff Media in the Immediate Post-operative Cardiac Surgery Patient Population, and Its Effect on Sedation/Analgesia Requirements: a Pilot Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03343080
Enrollment
32
Registered
2017-11-17
Start date
2018-07-27
Completion date
2019-08-01
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

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

DRUG1.8% 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. 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.

OTHERAir

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

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Total Sedation Requirementsbaseline through extubationTotal amount of Propofol dose used as measured in total milligrams.

Secondary

MeasureTime frameDescription
Total Duration of Mechanical Ventilationbaseline through extubationTotal amount of time that the participant is intubated as measured in minutes.
Richmond Agitation-Sedation Score (RASS)4 hours post-extubationThe 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

ArmCount
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
Total32

Baseline characteristics

CharacteristicAir OnlyTotalBuffered Lidocaine
Age, Continuous59.4 years
STANDARD_DEVIATION 16.6
60.7 years
STANDARD_DEVIATION 15.8
62.1 years
STANDARD_DEVIATION 14.9
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
18 participants32 participants14 participants
Sex: Female, Male
Female
7 Participants10 Participants3 Participants
Sex: Female, Male
Male
11 Participants22 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 18
other
Total, other adverse events
14 / 1418 / 18
serious
Total, serious adverse events
0 / 140 / 18

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Buffered LidocaineTotal Sedation Requirements325 milligramsStandard Deviation 248
Air OnlyTotal Sedation Requirements1158 milligramsStandard Deviation 1426
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Buffered LidocaineRichmond Agitation-Sedation Score (RASS)-0.2 score on a scaleStandard Deviation 0.4
Air OnlyRichmond Agitation-Sedation Score (RASS)-0.4 score on a scaleStandard Deviation 0.5
Comparison: 4 hours post-extubationp-value: 0.296t-test, 2 sided
Secondary

Total Duration of Mechanical Ventilation

Total amount of time that the participant is intubated as measured in minutes.

Time frame: baseline through extubation

ArmMeasureValue (MEDIAN)
Buffered LidocaineTotal Duration of Mechanical Ventilation499 minutes
Air OnlyTotal Duration of Mechanical Ventilation529 minutes
p-value: 0.776Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026