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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal intubation | Active Comparator | Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure |
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| Laryngeal mask airway | Experimental | Laryngeal mask for airway management and ventilation during sinonasal surgical procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mallinckrodt Endotracheal Tube (ETT) | Device | Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | 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). | intraoperative, within about 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia Time in Minutes | Start and stop time of anesthesia as recorded in anesthesia record | beginning and end of anesthesia (approximately 2 hours) |
| Recovery Time in Minutes | Minutes spent in recovery room as recorded in the recovery room record |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Turner, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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2 patients were consented and enrolled in the clinic setting, but they did not end up being randomized:
1 did not proceed with surgery
1 was diagnosed with sleep apnea, which is exclusionary
Recruitment was completed in clinic and the pre-operative surgical area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endotracheal Intubation | Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT. |
| FG001 | Laryngeal Mask Airway | Laryngeal mask for airway management and ventilation during sinonasal surgical procedure Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Endotracheal Intubation | Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT. |
| BG001 | Laryngeal Mask Airway |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Date of birth was collected from the medical record and confirmed at date of surgery. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | 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). | Participants that started the study were analyzed. Data was missing for 1 participant in each arm. | Posted | Count of Participants | Participants | intraoperative, within about 1 hour |
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Patients are monitored for adverse events from the start of surgery through hospital discharge (approximately 6 hours) and are contacted again at first post-op visit, about 5 to 7 days later.
Throughout the surgical procedure, the patient is monitored for any adverse events including desaturation of oxygen saturation, the occurrence of bronchospasm, laryngospasm, and other airway complications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endotracheal Intubation | Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure Mallinckrodt Endotracheal Tube (ETT): Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin H. Turner, MD, PhD | Vanderbilt University Medical Center | justin.h.turner@vanderbilt.edu |
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| Laryseal Laryngeal mask airway (LMA) | Device | Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. |
|
| time spent in recovery room after surgery (approximately 4 hours) |
| Presence of Laryngeal Spasm | As recorded in anesthesia care record | From start of anesthesia through hospital discharge (approximately 6 hours) |
| Post-op Pain Med Requirements | Recording pain medications given to patient as noted in the recovery room records and medication administration record | 48 hour medicine requirement |
| Presence or Absence of Airway Complications | Start of surgery through hospital discharge (approximately 6 hours) |
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Sex was recorded from the medical record, with in-person confirmation at clinic visit(s). | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Laryngeal Mask Airway |
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. |
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| Secondary | Anesthesia Time in Minutes | Start and stop time of anesthesia as recorded in anesthesia record | Posted | Mean | Full Range | minutes | beginning and end of anesthesia (approximately 2 hours) |
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| Secondary | Recovery Time in Minutes | Minutes spent in recovery room as recorded in the recovery room record | Participants that started the study were analyzed. | Posted | Mean | Full Range | minutes | time spent in recovery room after surgery (approximately 4 hours) |
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| Secondary | Presence of Laryngeal Spasm | As recorded in anesthesia care record | Posted | Count of Participants | Participants | From start of anesthesia through hospital discharge (approximately 6 hours) |
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| Secondary | Post-op Pain Med Requirements | Recording pain medications given to patient as noted in the recovery room records and medication administration record | Participants that started the study were analyzed. Data was missing for 5 participants in the Endotracheal intubation arm and 7 participants in the Laryngeal mask airway arm. | Posted | Count of Participants | Participants | 48 hour medicine requirement |
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| Secondary | Presence or Absence of Airway Complications | Participants that started the study were analyzed. | Posted | Count of Participants | Participants | Start of surgery through hospital discharge (approximately 6 hours) |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Laryngeal Mask Airway | Laryngeal mask for airway management and ventilation during sinonasal surgical procedure Laryseal Laryngeal mask airway (LMA): Laryseal Laryngeal mask airway is used to provide airway protection and ventilation. | 0 | 49 | 0 | 49 | 0 | 49 |
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| 5-9 pills |
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| 1-4 pills |
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| No pain meds taken |
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