Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT02311153
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
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).
Time frame: beginning and end of anesthesia (approximately 2 hours)
Start and stop time of anesthesia as recorded in anesthesia record
Time frame: time spent in recovery room after surgery (approximately 4 hours)
Minutes spent in recovery room as recorded in the recovery room record
Time frame: From start of anesthesia through hospital discharge (approximately 6 hours)
As recorded in anesthesia care record
Time frame: 48 hour medicine requirement
Recording pain medications given to patient as noted in the recovery room records and medication administration record
Time frame: Start of surgery through hospital discharge (approximately 6 hours)
Vanderbilt University Medical Center
Other
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