Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique

Summary

Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia.

Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway.

The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.

Conditions

• Limit Emergence Phenomena After General Anesthesia

Interventions

PROCEDURE

Induction of anesthesia

At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent

DEVICE

Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]

By standard method. Sizing at the discretion of the primary anesthesiologist.

DEVICE

Laryngoscopy and placement of ETT

Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)

PROCEDURE

Ventilation via the ETT

Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.

PROCEDURE

Removal of the ETT

Either upon emergence of anesthesia after suctioning of the oropharynx and after a positive pressure breath or while deeply anesthetized after release of the pneumoperitoneum in the combined LMA/ETT group.

PROCEDURE

Intubation of the trachea through the LMA

With ETT using fiberoptic bronchoscope guidance.

PROCEDURE

Ventilation via the LMA

After removal of the ETT. Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.

PROCEDURE

Emergence from anesthesia

At the discretion of primary team. Airway device (either ETT or LMA) will be removed when patient is adequately ventilating and able to respond to commands (such as "open your eyes" or "squeeze my hand").

Sponsors & Collaborators

• Ambu A/S

  collaborator INDUSTRY

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Arne Budde, MD · Penn State M.S. Hershey Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2026-06-01

Completion

2026-06-01

FDA Device

Yes

Countries

• United States

Study Locations