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Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311153
Recruitment Status : Completed
First Posted : December 8, 2014
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Justin Turner, Vanderbilt University Medical Center

Brief Summary:
Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate the safety and efficacy of LMA for airway management during sinonasal surgery by directly comparing them to endotracheal intubation in a prospective randomized single‐blind study.

Condition or disease Intervention/treatment Phase
Conditions Requiring Sinonasal Surgery Device: Mallinckrodt Endotracheal Tube (ETT) Device: Laryseal Laryngeal mask airway (LMA) Not Applicable

Detailed Description:

LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike, as a safe mode of airway management when delivering general anesthesia. In sinonasal surgery, however, there are more concerns regarding the use of LMA's for airway management. Due to the nature of sinonasal procedures, the patient is exposed to blood and secretions that may drip/flow from the nasal cavity into the oropharynx and potentially into the upper and lower airways if not protected adequately. Additionally, often times, manipulation of the patient's head throughout the procedure is encountered to improve operative positioning. As a result, both surgeons and anesthesiologists have been hesitant to utilize LMA's in these types of surgeries despite documented benefits of increased patient comfort, fewer hemodynamic fluctuations during induction of anesthesia, and better controlled emergence when using LMA's.

Specific Aims The overall purpose of this study is to demonstrate the ability to provide safe and effective ventilation and airway protection with a laryngeal mask airway (LMA) during sinonasal surgery, by directly comparing them to endotracheal intubation in a prospective randomized single‐blind study.

Aim 1: Analyze and compare the incidence and severity of airway contamination/aspiration of blood and secretions during sinonasal surgery and reveal any statistically significant difference between LMA and endotracheal intubation.

Aim 2: Analyze and compare the incidence of various outcome measures including laryngospasm, bronchospasm, anesthesia time, recovery time, post‐op pain medication requirements, and airway complications between LMA and endotracheal intubation.

Aim 3: Analyze and compare both patient comfort and surgeon satisfaction after procedure between LMA and endotracheal intubation groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
Actual Study Start Date : November 25, 2014
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Endotracheal intubation
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
Device: Mallinckrodt Endotracheal Tube (ETT)
Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.

Experimental: Laryngeal mask airway
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Device: Laryseal Laryngeal mask airway (LMA)
Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.




Primary Outcome Measures :
  1. Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score [ Time Frame: intraoperative, within about 1 hour ]
    Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).


Secondary Outcome Measures :
  1. Anesthesia Time in Minutes [ Time Frame: beginning and end of anesthesia (approximately 2 hours) ]
    Start and stop time of anesthesia as recorded in anesthesia record

  2. Recovery Time in Minutes [ Time Frame: time spent in recovery room after surgery (approximately 4 hours) ]
    Minutes spent in recovery room as recorded in the recovery room record

  3. Presence of Laryngeal Spasm [ Time Frame: From start of anesthesia through hospital discharge (approximately 6 hours) ]
    As recorded in anesthesia care record

  4. Post-op Pain Med Requirements [ Time Frame: 48 hour medicine requirement ]
    Recording pain medications given to patient as noted in the recovery room records and medication administration record

  5. Presence or Absence of Airway Complications [ Time Frame: Start of surgery through hospital discharge (approximately 6 hours) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (18 yo or older) undergoing elective sinonasal procedures including rhinoplasty, septoplasty, and paranasal sinus surgery estimated blood loss will be less than 300cc and the length of the procedure will be expected to last 2 hours or less
  • American Society of Anesthesiologists (ASA) scores 1‐3
  • Mallampati classification 1‐3

Exclusion Criteria:

  • Currently pregnant
  • History of obstructive sleep apnea with history of difficulty with ventilation
  • Mouth opening less than 3cm
  • Indications for fiberoptic intubation present
  • Upper aerodigestive tract mass or malignancy
  • Procedure deemed emergent
  • Severe gastroesophageal reflux, severe cardiac, pulmonary, renal or hepatic co‐morbidities
  • Unable to consent to study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311153


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Justin Turner, MD, PhD Vanderbilt University Medical Center
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Responsible Party: Justin Turner, Assistant Professor of Otolaryngology-Head and Neck Surgery, Assistant Professor of Biomedical Engineering, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02311153    
Other Study ID Numbers: 141421
First Posted: December 8, 2014    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided