Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
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|ClinicalTrials.gov Identifier: NCT02311153|
Recruitment Status : Completed
First Posted : December 8, 2014
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Conditions Requiring Sinonasal Surgery||Device: Mallinckrodt Endotracheal Tube (ETT) Device: Laryseal Laryngeal mask airway (LMA)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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).
- 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
- 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
- Presence of Laryngeal Spasm [ Time Frame: From start of anesthesia through hospital discharge (approximately 6 hours) ]As recorded in anesthesia care record
- 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
- Presence or Absence of Airway Complications [ Time Frame: Start of surgery through hospital discharge (approximately 6 hours) ]
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
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Justin Turner, MD, PhD||Vanderbilt University Medical Center|