Lidocaine as an Endotracheal Tube (ETT) Cuff Media

NCT03343080 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 16-000621
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Keywords

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Total Sedation Requirements

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

  baseline through extubation

Secondary Outcomes (2)

• Total Duration of Mechanical Ventilation

  baseline through extubation

• Richmond Agitation-Sedation Score (RASS)

  4 hours post-extubation

Study Arms (2)

Buffered Lidocaine

EXPERIMENTAL

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

Air

PLACEBO COMPARATOR

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

Interventions

1.8% lidocaine plus 0.76% sodium bicarbonate DRUG

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.

Buffered Lidocaine

Air OTHER

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.

Air

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Diseases

Interventions

Lidocaine; Sodium Bicarbonate; Air

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Dr. Troy Seelhammer
• Organization: Mayo Clinic

seelhammer.troy@mayo.edu

507-255-6051

Study Officials

• Troy G Seelhammer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: July 27, 2018
• Primary Completion: October 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)