Clinical trial NCT02311153: Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
Official title: Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions Requiring Sinonasal Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
timeFrame: intraoperative, within about 1 hour
Secondary outcomes:
measure: Anesthesia Time in Minutes
timeFrame: beginning and end of anesthesia (approximately 2 hours)
measure: Recovery Time in Minutes
timeFrame: time spent in recovery room after surgery (approximately 4 hours)
measure: Presence of Laryngeal Spasm
timeFrame: From start of anesthesia through hospital discharge (approximately 6 hours)
measure: Post-op Pain Med Requirements
timeFrame: 48 hour medicine requirement
measure: Presence or Absence of Airway Complications
timeFrame: Start of surgery through hospital discharge (approximately 6 hours)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Justin Turner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: