Recruiting

Airway Management

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT02708836

Conditions

Limit Emergence Phenomena After General Anesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Induction of anesthesia

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

Laryngoscopy and placement of ETT

Ventilation via the ETT

Removal of the ETT

Study Details

Brief 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

Study ID

NCT02708836

Start date

Jan 1, 2020

Status verified date

Jul, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ASA 1-3
  • Patients undergoing elective laparoscopic surgery

Exclusion Criteria:

  • Individuals who cannot provide consent
  • Individuals who would require translation services to provide consent
  • Prisoners
  • Parturients
  • Non-fasted patients (as per HMC Anesthesiology Department NPO policy)
  • Patients felt to be high risk for gastric reflux and pulmonary aspiration (those with gastroparesis, symptomatic GERD, etc.: at the discretion of primary anesthesia team) Those patients with anticipated difficult airway requiring maintenance of spontaneous ventilation (awake intubation)

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Induction of anesthesia

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]

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

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)

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.

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.

Intubation of the trachea through the LMA

With ETT using fiberoptic bronchoscope guidance.

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.

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").

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Arne Budde, MD

717-531-6140abudde@pennstatehealth.psu.edu

Cynthia Reed, Bachelor of Science

717-531-0003creed@pennstatehealth.psu.edu

Locations

Penn State Health - Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Arne Budde, MD

7175316140abudde@pennstatehealth.psu.edu

Principal Investigator:

Arne Budde, MD

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-07-17.