Lidocaine as an Endotracheal Tube (ETT) Cuff Media



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:July 27, 2018
End Date:August 31, 2019

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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

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.

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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Troy G Seelhammer, MD
Phone: 507-538-2263
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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