Trial Outcomes & Findings for Lidocaine as an Endotracheal Tube (ETT) Cuff Media (NCT NCT03343080)

NCT ID: NCT03343080

Last Updated: 2019-09-27

Results Overview

Total amount of Propofol dose used as measured in total milligrams.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline through extubation
• Results posted on: 2019-09-27

Participant Flow

Participant milestones

Measure	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	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.
Overall Study STARTED	14	18
Overall Study COMPLETED	14	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Buffered Lidocaine n=14 Participants 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	Air Only n=18 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 14.9 • n=14 Participants	59.4 years STANDARD_DEVIATION 16.6 • n=18 Participants	60.7 years STANDARD_DEVIATION 15.8 • n=32 Participants
Sex: Female, Male Female	3 Participants n=14 Participants	7 Participants n=18 Participants	10 Participants n=32 Participants
Sex: Female, Male Male	11 Participants n=14 Participants	11 Participants n=18 Participants	22 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	18 participants n=18 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: 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.

Total amount of Propofol dose used as measured in total milligrams.

Outcome measures

Measure	Buffered Lidocaine n=10 Participants 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	Air Only n=13 Participants 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.
Total Sedation Requirements	325 milligrams Standard Deviation 248	1158 milligrams Standard Deviation 1426

SECONDARY outcome

Timeframe: baseline through extubation

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

Outcome measures

Measure	Buffered Lidocaine n=14 Participants 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	Air Only n=18 Participants 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.
Total Duration of Mechanical Ventilation	499 minutes Interval 440.0 to 613.0	529 minutes Interval 380.0 to 700.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Buffered Lidocaine n=14 Participants 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	Air Only n=18 Participants 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.
Richmond Agitation-Sedation Score (RASS)	-0.2 score on a scale Standard Deviation 0.4	-0.4 score on a scale Standard Deviation 0.5

Adverse Events

Buffered Lidocaine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Air Only

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Buffered Lidocaine n=14 participants at risk 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	Air Only n=18 participants at risk 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.
General disorders Agitation or restlessness	0.00% 0/14 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.	5.6% 1/18 • Number of events 1 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.
General disorders Difficulty swallowing	7.1% 1/14 • Number of events 1 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.	11.1% 2/18 • Number of events 2 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.
General disorders Hoarseness present	71.4% 10/14 • Number of events 10 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.	83.3% 15/18 • Number of events 15 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.
General disorders Cough	28.6% 4/14 • Number of events 4 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.	38.9% 7/18 • Number of events 7 • Adverse events were recorded from baseline to 4 hours post extubation for each subject.

Additional Information

Dr. Troy Seelhammer

Mayo Clinic

Phone: 507-255-6051

Email: seelhammer.troy@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place