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

Conditions

• Limit Emergence Phenomena After General Anesthesia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Induction of anesthesia — PROCEDURE
  At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
• Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask] — DEVICE
  By standard method. Sizing at the discretion of the primary anesthesiologist.
• Laryngoscopy and placement of ETT — DEVICE
  Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)
• Ventilation via the ETT — PROCEDURE
  Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
• Removal of the ETT — PROCEDURE
  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.
• Intubation of the trachea through the LMA — PROCEDURE
  With ETT using fiberoptic bronchoscope guidance.
• Ventilation via the LMA — PROCEDURE
  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.
• Emergence from anesthesia — PROCEDURE
  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").

Study Details

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.

Key Dates

Start date

Jan 1, 2020

Status verified

Aug 2025

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: ETT only
  Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.
• Experimental: Combined ETT/LMA technique
  Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.

Primary Outcome Measure

Change in rate pressure product during emergence [ Time Frame: Intraoperative ]

Central Contacts

• Arne Budde, MD
  717-531-6140
  [email protected]
• Cynthia Reed, Bachelor of Science
  717-531-0003
  [email protected]

Locations (1)

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