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

NCT02708836 | Recruiting FDA Device

• 1 other identifier: 00004373
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in rate pressure product during emergence

  Difference in heart rate multiplied by systolic blood pressure measured during the \~5 minutes prior to emergence and the \~5 minutes after removal of the airway device. Heart rate is continuously monitored and recorded at one minute intervals. Blood pressure is intermittently monitored at 3 minute intervals. The two SBPs measured prior to removal of the airway device will be multiplied by the HR at those times and the RPPs will be averaged. This will be compared with average of the product of the two SBPs and their corresponding HRs measured after removal of the airway device.

  Intraoperative

Secondary Outcomes (10)

• Time to successful ventilation via ETT

  Intraoperative

• Change in rate pressure product during induction of anesthesia and intubation

  Intraoperative

• Success rate of ventilation with LMA after extubation of trachea

  Intraoperative

• Presence/ severity of cough during prior to removal of airway device

  Intraoperative

• Presence/ severity of cough during after removal of airway device

  Intraoperative

Study Arms (2)

ETT only

ACTIVE COMPARATOR

Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.

Procedure: Induction of anesthesia; Device: Laryngoscopy and placement of ETT; Procedure: Ventilation via the ETT; Procedure: Removal of the ETT; Procedure: Emergence from anesthesia

Combined ETT/LMA technique

EXPERIMENTAL

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.

Procedure: Induction of anesthesia; Device: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]; Procedure: Ventilation via the ETT; Procedure: Removal of the ETT; Procedure: Intubation of the trachea through the LMA; Procedure: Ventilation via the LMA; Procedure: Emergence from anesthesia

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

Combined ETT/LMA technique; ETT only

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

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

Combined ETT/LMA technique

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)

ETT only

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.

Combined ETT/LMA technique; ETT only

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.

Combined ETT/LMA technique; ETT only

Intubation of the trachea through the LMA PROCEDURE

With ETT using fiberoptic bronchoscope guidance.

Combined ETT/LMA technique

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.

Combined ETT/LMA technique

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").

Combined ETT/LMA technique; ETT only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-3
• Patients undergoing elective laparoscopic surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Ambu A/S: collaborator

Study Sites (1)

Penn State Health - Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Related Publications (17)

• Difficult Airway Society Extubation Guidelines Group; Popat M, Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia. 2012 Mar;67(3):318-40. doi: 10.1111/j.1365-2044.2012.07075.x.

  PMID: 22321104 RESULT

• Atkinson RS, Rushman GB, Alfred Lee J: A Synopsis of Anaesthesia, 10th edition. Butterworth-Heinemann Ltd, 1987, pp 165-9

  RESULT

• Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.

  PMID: 9709138 RESULT

• Perello-Cerda L, Fabregas N, Lopez AM, Rios J, Tercero J, Carrero E, Hurtado P, Hervias A, Gracia I, Caral L, de Riva N, Valero R. ProSeal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients: A Randomized Clinical Trial. J Neurosurg Anesthesiol. 2015 Jul;27(3):194-202. doi: 10.1097/ANA.0000000000000108.

  PMID: 25121397 RESULT

• Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.

  PMID: 15385385 RESULT

• Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.

  PMID: 19864308 RESULT

• Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.

  PMID: 16095449 RESULT

• Natalini G, Lanza G, Rosano A, Dell'Agnolo P, Bernardini A. Standard Laryngeal Mask Airway and LMA-ProSeal during laparoscopic surgery. J Clin Anesth. 2003 Sep;15(6):428-32. doi: 10.1016/s0952-8180(03)00085-0.

  PMID: 14652119 RESULT

• Beleña JM, Núñez M, Gracia JL, Pérez JL, Yuste J. The Laryngeal Mask Airway Supreme™: safety and efficacy during gynaecological laparoscopic surgery. Southern African Journal of Anaesthesia and Analgesia 18: 143-7, 2012.

  RESULT

• Carron M, Veronese S, Gomiero W, Foletto M, Nitti D, Ori C, Freo U. Hemodynamic and hormonal stress responses to endotracheal tube and ProSeal Laryngeal Mask Airway for laparoscopic gastric banding. Anesthesiology. 2012 Aug;117(2):309-20. doi: 10.1097/ALN.0b013ef31825b6a80.

  PMID: 22614132 RESULT

• Bernardini A, Natalini G. Risk of pulmonary aspiration with laryngeal mask airway and tracheal tube: analysis on 65 712 procedures with positive pressure ventilation. Anaesthesia. 2009 Dec;64(12):1289-94. doi: 10.1111/j.1365-2044.2009.06140.x. Epub 2009 Oct 23.

  PMID: 19860753 RESULT

• Nair I, Bailey PM. Use of the laryngeal mask for airway maintenance following tracheal extubation. Anaesthesia. 1995 Feb;50(2):174-5. doi: 10.1111/j.1365-2044.1995.tb15104.x. No abstract available.

  PMID: 7710032 RESULT

• Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.

  PMID: 22074079 RESULT

• Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.

  PMID: 25254120 RESULT

• Lehnert B, Prescher A, Neuschaefer-Rube C. Is laryngeal mask airway-related vocal chord palsy always laryngeal mask airway-related? Br J Anaesth. 2008 Dec;101(6):882. doi: 10.1093/bja/aen304. No abstract available.

  PMID: 19004921 RESULT

• El Toukhy M, Tweedie O. Bilateral lingual nerve injury associated with classic laryngeal mask airway: a case report. Eur J Anaesthesiol. 2012 Aug;29(8):400-1. doi: 10.1097/EJA.0b013e3283514e81. No abstract available.

  PMID: 22472625 RESULT

• Shah AC, Barnes C, Spiekerman CF, Bollag LA. Hypoglossal nerve palsy after airway management for general anesthesia: an analysis of 69 patients. Anesth Analg. 2015 Jan;120(1):105-120. doi: 10.1213/ANE.0000000000000495.

  PMID: 25625257 RESULT

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Arne Budde, MD

  Penn State M.S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arne Budde, MD

CONTACT

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

Cynthia Reed, Bachelor of Science

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 15, 2016
• Study Start: January 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)