Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

NCT ID: NCT02311153

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-25
• Study Completion Date: 2017-12-31

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.

Conditions

Conditions Requiring Sinonasal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endotracheal intubation

Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure

Group Type: ACTIVE_COMPARATOR

Mallinckrodt Endotracheal Tube (ETT)

Intervention Type: DEVICE

Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.

Laryngeal mask airway

Laryngeal mask for airway management and ventilation during sinonasal surgical procedure

Group Type: EXPERIMENTAL

Laryseal Laryngeal mask airway (LMA)

Intervention Type: DEVICE

Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.

Interventions

Mallinckrodt Endotracheal Tube (ETT)

Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.

Intervention Type: DEVICE

Laryseal Laryngeal mask airway (LMA)

Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Justin Turner

Assistant Professor of Otolaryngology-Head and Neck Surgery, Assistant Professor of Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Turner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

141421

Identifier Type: -

Identifier Source: org_study_id