Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Conditions Requiring Sinonasal Surgery
• Intervention / Treatment: Device: Mallinckrodt Endotracheal Tube (ETT); Device: Laryseal Laryngeal mask airway (LMA)

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score	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).	intraoperative, within about 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Time in Minutes	Start and stop time of anesthesia as recorded in anesthesia record	beginning and end of anesthesia (approximately 2 hours)
Recovery Time in Minutes	Minutes spent in recovery room as recorded in the recovery room record	time spent in recovery room after surgery (approximately 4 hours)
Presence of Laryngeal Spasm	As recorded in anesthesia care record	From start of anesthesia through hospital discharge (approximately 6 hours)
Post-op Pain Med Requirements	Recording pain medications given to patient as noted in the recovery room records and medication administration record	48 hour medicine requirement
Presence or Absence of Airway Complications		Start of surgery through hospital discharge (approximately 6 hours)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Justin Turner, MD, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2014
• Primary Completion (Actual): July 26, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 141421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED