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

September 11, 2023 updated by: Justin Pachuski, Milton S. Hershey Medical Center

Limiting Emergence Phenomena After General Anesthesia for Laparoscopic Surgery With Combined Laryngeal Mask Airway and Endotracheal Tube Airway Management Technique

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Emergence from general anesthesia is a critical period of anesthetic management (1. Popat, 2012). The noxious stimuli of an endotracheal tube as well as the excitement stage of anesthesia, commonly seen prior to return of consciousness while emerging from general anesthesia, both lead to emergence phenomena of coughing, straining, and restlessness in addition to physiologic derangements (2. Atkinson, 1987). Physiologically, emergence from anesthesia is associated with rising sympathetic tone (as evidenced by elevated catecholamine levels and the resultant hemodynamic changes of increasing heart rate and blood pressure), intracranial pressure, and intraocular pressure. Airway tone and reflexes are also problematic as they may be depressed by the lingering pharmacologic effects of anesthetics and analgesics leading to decreased airway obstruction or aspiration events. Airway reflexes may also be exaggerated while traversing the excitement stage; this can lead to undesirable consequences of coughing, breath-holding, bucking or in extreme cases laryngospasm. A smooth emergence is preferable for all patients but is required for those patients who would not tolerate the above physiologic changes (e.g. severe aortic stenosis or coronary artery disease, both of which would poorly tolerate tachycardia) or those would be at risk in terms of the procedure that was performed (cerebral aneurysm clipping, carotid endarterectomy, thyroidectomy: procedures in which stress fresh surgical wounds with hypertension and straining would be undesirable).

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health - Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Justin Pachuski, MD
        • Sub-Investigator:
          • Diane McCloskey, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ETT only
Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.
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: 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: 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").
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.
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
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: 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").
Device: Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]
By standard method. Sizing at the discretion of the primary anesthesiologist.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rate pressure product during emergence
Time Frame: Intraoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to successful ventilation via ETT
Time Frame: Intraoperative
From administration of induction medication until ETT placement confirmed via capnography.
Intraoperative
Change in rate pressure product during induction of anesthesia and intubation
Time Frame: Intraoperative
Difference in heart rate multiplied by systolic blood pressure measured during the ~5 minutes prior to induction of anesthesia and the ~5 minutes after placement 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 placement 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 placement of the airway device.
Intraoperative
Success rate of ventilation with LMA after extubation of trachea
Time Frame: Intraoperative

After deflation of the pneumoperitoneum, the ETT will be removed and ventilation will be continued through the LMA.

Success will be graded as follows:

  1. Adequate ventilation via LMA without need for adjustment.
  2. Adequate ventilation via LMA after adjustment of LMA.
  3. Inadequate ventilation via LMA. Unable to successfully re-seat LMA and need to re-intubate.
Intraoperative
Presence/ severity of cough during prior to removal of airway device
Time Frame: Intraoperative

During 5 minutes prior to removal of airway device.

Cough will be graded as follows:

None Mild = 1 episode of unsustained coughing (< 5 s) Moderate = More than 1 episode of unsustained (<5 s) coughing Severe = Sustained bout(s) of coughing (>5 s) http://www.ncbi.nlm.nih.gov/pubmed/15385385 - (5. Minogue 2004)
Intraoperative
Presence/ severity of cough during after removal of airway device
Time Frame: Intraoperative

During 5 minutes after removal of airway device.

Cough will be graded as follows:

None Mild = 1 episode of unsustained coughing (< 5 s) Moderate = More than 1 episode of unsustained (<5 s) coughing Severe = Sustained bout(s) of coughing (>5 s) http://www.ncbi.nlm.nih.gov/pubmed/15385385 - (5. Minogue 2004)
Intraoperative
Total opioids (morphine equivalents) administered intraoperatively
Time Frame: Intraoperative
From pre-induction until patient hand-off to post-anesthesia care unit team. Total intraoperative narcotics will be converted to morphine equivalents.
Intraoperative
LMA cuff pressures when inflated to seal
Time Frame: Intraoperative
After placement of LMA and LMA cuff inflated to seal. Pressure in the cuff will be measured and then deflated to pressures of 50-60 cmH20.
Intraoperative
LMA cuff pressures prior to removal of ETT.
Time Frame: Intraoperative
After deflation of the pneumoperitoneum. Pressure in the cuff will be measured and then deflated to pressures of 50-60 cmH20.
Intraoperative
Presence of oropharyngeal sensory or motor nerve palsy.
Time Frame: Up to 1 week
Postoperative day 3-5. A phone call will be made to determine the number of participants with the presence of any oropharyngeal numbness / paresthesias, hoarseness (recurrent laryngeal n. - Lehnert, 2008), dysphagia/ dysarthria (hypoglossal n. - Takahoko, 2014 & Shah, 2015), decreased sensation and sense of taste (lingual n. - El Toukhy, 2012) that could be indicative of a neuropraxia versus nerve palsy.
Up to 1 week
Presence of sore throat.
Time Frame: Up to 1 week
Postoperative day 3-5. A phone call will be made to determine the number of participants with sore throat (subjectively rated as none, mild, or severe).
Up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Ambu A/S

Investigators

  • Principal Investigator: Justin Pachuski, MD, Penn State M.S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimated)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00004373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be stored in REDCap, a HIPPA compliant secured and encrypted electronic database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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