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OpenTrials
Completed

NCT Number: NCT02311153

Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mallinckrodt Endotracheal Tube (ETT)

Device

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

Laryseal Laryngeal mask airway (LMA)

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. Presence of Laryngeal Spasm

    Time frame: From start of anesthesia through hospital discharge (approximately 6 hours)

    As recorded in anesthesia care record

  4. 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

  5. Presence or Absence of Airway Complications

    Time frame: Start of surgery through hospital discharge (approximately 6 hours)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 8, 2014
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.