Conditions Requiring Sinonasal Surgery
Conditions
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.
Interventions
DEVICEMallinckrodt Endotracheal Tube (ETT)
Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
DEVICELaryseal Laryngeal mask airway (LMA)
Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Time in Minutes | beginning and end of anesthesia (approximately 2 hours) | Start and stop time of anesthesia as recorded in anesthesia record |
| Recovery Time in Minutes | 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 | From start of anesthesia through hospital discharge (approximately 6 hours) | As recorded in anesthesia care record |
| Post-op Pain Med Requirements | 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 | Start of surgery through hospital discharge (approximately 6 hours) | — |
Countries
United States
Participant flow
Recruitment details
Recruitment was completed in clinic and the pre-operative surgical area.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 49 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Endotracheal Intubation | Laryngeal Mask Airway | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 4 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 45 Participants | 80 Participants |
| Region of Enrollment United States | 53 participants | 49 participants | 102 participants |
| Sex: Female, Male Female | 25 Participants | 29 Participants | 54 Participants |
| Sex: Female, Male Male | 28 Participants | 20 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 49 |
| other Total, other adverse events | 0 / 53 | 0 / 49 |
| serious Total, serious adverse events | 0 / 53 | 0 / 49 |
Outcome results
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).
Time frame: intraoperative, within about 1 hour
Population: Participants that started the study were analyzed. Data was missing for 1 participant in each arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endotracheal Intubation | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 0 | 12 Participants |
| Endotracheal Intubation | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 1 | 15 Participants |
| Endotracheal Intubation | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 2 | 15 Participants |
| Endotracheal Intubation | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 3 | 10 Participants |
| Laryngeal Mask Airway | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 3 | 7 Participants |
| Laryngeal Mask Airway | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 0 | 10 Participants |
| Laryngeal Mask Airway | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 2 | 10 Participants |
| Laryngeal Mask Airway | Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score | Soilage score 1 | 21 Participants |
Secondary
Anesthesia Time in Minutes
Start and stop time of anesthesia as recorded in anesthesia record
Time frame: beginning and end of anesthesia (approximately 2 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endotracheal Intubation | Anesthesia Time in Minutes | 61 minutes |
| Laryngeal Mask Airway | Anesthesia Time in Minutes | 49 minutes |
Secondary
Post-op Pain Med Requirements
Recording pain medications given to patient as noted in the recovery room records and medication administration record
Time frame: 48 hour medicine requirement
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endotracheal Intubation | Post-op Pain Med Requirements | No pain meds taken | 22 Participants |
| Endotracheal Intubation | Post-op Pain Med Requirements | > 15 pills | 0 Participants |
| Endotracheal Intubation | Post-op Pain Med Requirements | 10-14 pills | 2 Participants |
| Endotracheal Intubation | Post-op Pain Med Requirements | 5-9 pills | 3 Participants |
| Endotracheal Intubation | Post-op Pain Med Requirements | 1-4 pills | 21 Participants |
| Laryngeal Mask Airway | Post-op Pain Med Requirements | 1-4 pills | 13 Participants |
| Laryngeal Mask Airway | Post-op Pain Med Requirements | 5-9 pills | 8 Participants |
| Laryngeal Mask Airway | Post-op Pain Med Requirements | > 15 pills | 0 Participants |
| Laryngeal Mask Airway | Post-op Pain Med Requirements | No pain meds taken | 18 Participants |
| Laryngeal Mask Airway | Post-op Pain Med Requirements | 10-14 pills | 3 Participants |
Secondary
Presence of Laryngeal Spasm
As recorded in anesthesia care record
Time frame: From start of anesthesia through hospital discharge (approximately 6 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endotracheal Intubation | Presence of Laryngeal Spasm | 0 Participants |
| Laryngeal Mask Airway | Presence of Laryngeal Spasm | 0 Participants |
Secondary
Presence or Absence of Airway Complications
Time frame: Start of surgery through hospital discharge (approximately 6 hours)
Population: Participants that started the study were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endotracheal Intubation | Presence or Absence of Airway Complications | Presence of airway complications | 0 Participants |
| Endotracheal Intubation | Presence or Absence of Airway Complications | Absence of airway complicaitons | 53 Participants |
| Laryngeal Mask Airway | Presence or Absence of Airway Complications | Presence of airway complications | 0 Participants |
| Laryngeal Mask Airway | Presence or Absence of Airway Complications | Absence of airway complicaitons | 49 Participants |
Secondary
Recovery Time in Minutes
Minutes spent in recovery room as recorded in the recovery room record
Time frame: time spent in recovery room after surgery (approximately 4 hours)
Population: Participants that started the study were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Endotracheal Intubation | Recovery Time in Minutes | PACU phase 1 time | 34.5 minutes |
| Endotracheal Intubation | Recovery Time in Minutes | PACU phase 2 time | 37.5 minutes |
| Laryngeal Mask Airway | Recovery Time in Minutes | PACU phase 1 time | 30 minutes |
| Laryngeal Mask Airway | Recovery Time in Minutes | PACU phase 2 time | 40 minutes |