Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

Not Applicable

Completed

Conditions: Conditions Requiring Sinonasal Surgery

Interventions: Device: Laryseal Laryngeal mask airway (LMA)
Device: Mallinckrodt Endotracheal Tube (ETT)

Registration Number: NCT02311153

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 104

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngeal mask airway	Laryseal Laryngeal mask airway (LMA)	Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
Endotracheal intubation	Mallinckrodt Endotracheal Tube (ETT)	Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure

Primary Outcome Measures

Name	Time	Method
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score	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

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