Airway Morbidity
Conditions
Keywords
Intubation, Airway, Laryngeal Mask Airway
Brief summary
A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the working end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.
Detailed description
The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented.
Interventions
OTHERGroup 1 Classic
Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
OTHERGroup 2 pre-inflated
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer.
OTHERGroup 3 ELL-PIC
Group 3 (ELL-PIC): Using the ELL-PIC technique
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ASA (American Society of Anesthesiologists patient fitness category) I, II, III * Age 18-90 * General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included
Exclusion criteria
* Small mouth opening * Preoperative sore throat/dysphagia/dysphonia * Patients at increased risk for aspiration * Morbid obesity BMI \> 40 * Untreated chronic GERD * Pregnancy * Suspected supraglottic abnormalities * N2O use * Need for oral-pharyngeal suctioning * Undergoing oral and nasal surgery * Intubation or any oral instrumental manipulations other than * LMA placements intraoperatively or postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Present With Postoperative Sore Throat | 24 hours | The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant. |
| The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia | 24 hours | The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement. |
| The Primary Outcomes for This Study Will be Postoperative Dysphagia. | 24 hours | The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant. |
| The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. | 24 hours | The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Sore Throat | 24 hours | Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour. Low pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours) |
| Blood on LMA After Removal | Immediately after LMA removal | Presence of blood immediately after the removal of the LMA after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual. | 150 |
| Group 2 Pre Inflated Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer. | 150 |
| Group 3 ELL-PIC Technique Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique | 150 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive allocated intervention | 3 | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Group 3 ELL-PIC Technique | Group 2 Pre Inflated | Total | Group 1 Classic |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 145 Participants | 441 Participants | 147 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 16 | 47 years STANDARD_DEVIATION 16 | 46 years STANDARD_DEVIATION 16 | 45 years STANDARD_DEVIATION 16 |
| ASA physical status ASA l | 70 ASA STATUS | 70 ASA STATUS | 214 ASA STATUS | 74 ASA STATUS |
| ASA physical status ASA ll | 76 ASA STATUS | 69 ASA STATUS | 212 ASA STATUS | 67 ASA STATUS |
| ASA physical status ASA lll | 3 ASA STATUS | 4 ASA STATUS | 11 ASA STATUS | 4 ASA STATUS |
| ASA physical status Not documented | 0 ASA STATUS | 2 ASA STATUS | 4 ASA STATUS | 2 ASA STATUS |
| BMI (kg/m∧2 ) | 27.8 BMI (kg/m∧2 ) STANDARD_DEVIATION 5.5 | 27.7 BMI (kg/m∧2 ) STANDARD_DEVIATION 5.8 | 27.7 BMI (kg/m∧2 ) STANDARD_DEVIATION 5.6 | 27.4 BMI (kg/m∧2 ) STANDARD_DEVIATION 5.2 |
| Duration of OMA device | 62 minutes | 65 minutes | 66 minutes | 71 minutes |
| Mallampati Class Class I | 64 participants | 60 participants | 193 participants | 69 participants |
| Mallampati Class Class II | 49 participants | 52 participants | 140 participants | 39 participants |
| Mallampati Class Class III | 24 participants | 20 participants | 64 participants | 20 participants |
| Mallampati Class Class IV | 12 participants | 13 participants | 44 participants | 19 participants |
| Neck Circumference (cm) | 38 centimeters | 38 centimeters | 38 centimeters | 38 centimeters |
| OMA Insertion attempts 1 attempt | 136 Participants | 126 Participants | 384 Participants | 122 Participants |
| OMA Insertion attempts 2 attempts | 12 Participants | 16 Participants | 49 Participants | 21 Participants |
| OMA Insertion attempts 3 attempts | 1 Participants | 3 Participants | 7 Participants | 3 Participants |
| OMA Insertion attempts 4 attempts | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| OSA insertion time in seconds | 56 Seconds | 54 Seconds | 55 Seconds | 54 Seconds |
| Perioperative opioid use Intraoperative opioid (morEq milligrams) | 10 morphine equivalents milligrams | 10 morphine equivalents milligrams | 10 morphine equivalents milligrams | 10 morphine equivalents milligrams |
| Perioperative opioid use Postoperative opioid (morEq milligrams)) | 1.4 morphine equivalents milligrams | 1.3 morphine equivalents milligrams | 1.4 morphine equivalents milligrams | 2.7 morphine equivalents milligrams |
| Perioperative opioid use Total opioid (morEq milligrams) | 13 morphine equivalents milligrams | 13 morphine equivalents milligrams | 13 morphine equivalents milligrams | 15 morphine equivalents milligrams |
| Region of Enrollment United States | 149 participants | 145 participants | 450 participants | 147 participants |
| Sex: Female, Male Female | 67 Participants | 60 Participants | 185 Participants | 58 Participants |
| Sex: Female, Male Male | 82 Participants | 85 Participants | 256 Participants | 89 Participants |
| Surgical Procedure Performed Breast and skin | 4 participants | 4 participants | 10 participants | 2 participants |
| Surgical Procedure Performed Elbow Artrhroscopy | 5 participants | 6 participants | 19 participants | 8 participants |
| Surgical Procedure Performed Hernia Repair | 3 participants | 1 participants | 7 participants | 3 participants |
| Surgical Procedure Performed Knee Arthroscopy | 93 participants | 85 participants | 273 participants | 95 participants |
| Surgical Procedure Performed Other | 0 participants | 1 participants | 1 participants | 0 participants |
| Surgical Procedure Performed Other Arthroscopy | 1 participants | 3 participants | 11 participants | 7 participants |
| Surgical Procedure Performed Procedure of the eye | 2 participants | 3 participants | 8 participants | 3 participants |
| Surgical Procedure Performed Shoulder Arthroscopy | 41 participants | 42 participants | 112 participants | 29 participants |
| Time to discharge Phase 1 immediate PACU (minutes) | 60 minutes | 63 minutes | 63 minutes | 67 minutes |
| Time to discharge Phase 2 PACU transition home (minutes) | 95 minutes | 95 minutes | 93 minutes | 90 minutes |
| Time to discharge Time to discharge (minutes) | 221 minutes | 236 minutes | 233 minutes | 240 minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 83 / 147 | 80 / 145 | 78 / 149 |
| serious Total, serious adverse events | 0 / 147 | 0 / 145 | 0 / 149 |
Outcome results
Primary
Number of Subjects Who Present With Postoperative Sore Throat
The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Classic | Number of Subjects Who Present With Postoperative Sore Throat | 71 Participants |
| Group 2 Pre Inflated | Number of Subjects Who Present With Postoperative Sore Throat | 71 Participants |
| Group 3 ELL-PIC Technique | Number of Subjects Who Present With Postoperative Sore Throat | 67 Participants |
Primary
The Primary Outcomes for This Study Will be Postoperative Dysphagia.
The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Classic | The Primary Outcomes for This Study Will be Postoperative Dysphagia. | 45 Participants |
| Group 2 Pre Inflated | The Primary Outcomes for This Study Will be Postoperative Dysphagia. | 38 Participants |
| Group 3 ELL-PIC Technique | The Primary Outcomes for This Study Will be Postoperative Dysphagia. | 34 Participants |
Primary
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Classic | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. | 83 Participants |
| Group 2 Pre Inflated | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. | 80 Participants |
| Group 3 ELL-PIC Technique | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. | 78 Participants |
Comparison: We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.p-value: 0.76Chi-squared
Primary
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia
The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Classic | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia | 39 Participants |
| Group 2 Pre Inflated | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia | 31 Participants |
| Group 3 ELL-PIC Technique | The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia | 25 Participants |
Secondary
Blood on LMA After Removal
Presence of blood immediately after the removal of the LMA after surgery.
Time frame: Immediately after LMA removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Classic | Blood on LMA After Removal | 26 Participants |
| Group 2 Pre Inflated | Blood on LMA After Removal | 24 Participants |
| Group 3 ELL-PIC Technique | Blood on LMA After Removal | 13 Participants |
Comparison: We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.p-value: 0.05Chi-squared
Secondary
Severity of Sore Throat
Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour. Low pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 Classic | Severity of Sore Throat | 143 units on a scale |
| Group 2 Pre Inflated | Severity of Sore Throat | 143 units on a scale |
| Group 3 ELL-PIC Technique | Severity of Sore Throat | 102 units on a scale |