Lidocaine as an Endotracheal Tube (ETT) Cuff Media

NCT ID: NCT03343080

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-27
• Study Completion Date: 2019-08-01

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.

Conditions

Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Buffered Lidocaine

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.

Group Type: EXPERIMENTAL

1.8% lidocaine plus 0.76% sodium bicarbonate

Intervention Type: 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.

Air

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.

Group Type: PLACEBO_COMPARATOR

Air

Intervention Type: 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.

Interventions

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. 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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Troy G. Seelhammer

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Troy G Seelhammer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-000621

Identifier Type: -

Identifier Source: org_study_id