Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique
NCT ID: NCT02708836
Last Updated: 2025-08-14
Study Results
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Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2020-01-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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Several airway management (3. Koga 1998, 4. Perello-Cerda 2015) and pharmacologic strategies (5. Minogue 20014, 6. Nho 2009, 7. Guler 2005) have been employed to provide a smooth emergence from general anesthesia. One of the most efficacious strategies is the use of supraglottic airway devices rather than endotracheal tubes. Despite evidence supporting the safety and efficacy of ventilation of SGAs during laparoscopic procedures (8. Natalini 2003, 9. Belena 2012, 10. Carron 2012, 11. Bernardini 2009), many anesthesiologists would prefer the use of an ETT to an SGA in cases in which higher ventilation pressures may be required (obesity, steep Trendeleberg position, pneumoperitoneum). In addition to the cases requiring high ventilation pressures, ETTs are preferred to SGAs in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents (non-fasted, intestinal obstruction, gastroparesis, parturients), as well as during cases that allow the anesthesiologist to have little accessibility the airway (neurosurgical, ENT, etc).
The Bailey maneuver (managing the airway with an ETT throughout the case and then exchanging for an LMA while deeply anesthetized (12. Nair 1995), has also been shown to provide less stimulating emergence. Unfortunately, the Bailey maneuver is relatively contraindicated in cases in which there is the perception that reintubation would be difficult, as the risks of exchanging a functioning airway device for one that has not been tested outweighs the potential benefits of a smooth emergence.
The airway management technique under investigation involves initially placing an LMA after induction of anesthesia. Once adequate ventilation has been accomplished using the LMA, the patient will be endotracheally intubated using a fiberoptic bronchoscope and the in situ LMA as a conduit (13. Timmermann 2011). General anesthesia will be maintained with sevoflurane and narcotics at the discretion of the primary anesthesiologist. The patient will be ventilated via the endotracheal tube during the duration of the surgical procedure and then the trachea will be extubated while the patient is at a deep plane of anesthesia after release of the pneumoperitoneum and return to supine positioning. This technique is a potential method for reducing the stress of emergence in patients who would benefit from the use of an endotracheal tube intraoperatively.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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ETT only
Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.
Induction of anesthesia
At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
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.
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").
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.
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.
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").
Interventions
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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").
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective laparoscopic surgery
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Ambu A/S
INDUSTRY
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Arne Budde
Associate Professor, Department of Anesthesiology and Perioperative Medicine
Principal Investigators
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Arne Budde, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State M.S. Hershey Medical Center
Locations
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Penn State Health - Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Atkinson RS, Rushman GB, Alfred Lee J: A Synopsis of Anaesthesia, 10th edition. Butterworth-Heinemann Ltd, 1987, pp 165-9
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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00004373
Identifier Type: -
Identifier Source: org_study_id
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