A New Insertion Technique for Laryngeal Mask Airway

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01749033
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Arms: 3
• Duration (Months): 49
• Patients Per Site Per Month: 9.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Morbidity	Other: Group 1 Classic; Other: Group 2 pre-inflated; Other: Group 3 ELL-PIC	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A New Insertion Technique for Laryngeal Mask Airway
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual.	Other: Group 1 Classic; Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Active Comparator: Group 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	Other: Group 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.
Active Comparator: Group 3 ELL-PIC technique Group 3 (ELL-PIC): Using the ELL-PIC technique.	Other: Group 3 ELL-PIC; Group 3 (ELL-PIC): Using the ELL-PIC technique

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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 Outcome Measures

1. 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)

2. Blood on LMA After Removal [Immediately after LMA removal]

   Presence of blood immediately after the removal of the LMA after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Study Director: David Walega, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Walega, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01749033
• Other Study ID Numbers: STU00046964
• First Posted: Dec 13, 2012
• Last Update Posted: Dec 17, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by David Walega, Principal Investigator, Northwestern University: Intubation; Airway; Laryngeal Mask Airway

Study Results

Participant Flow

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Period Title: Overall Study
STARTED	150	150	150
COMPLETED	147	145	149
NOT COMPLETED	3	5	1

Baseline Characteristics

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique	Total
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique	Total of all reporting groups
Overall Participants	150	150	150	450
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	147 98%	145 96.7%	149 99.3%	441 98%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (16)	47 (16)	46 (16)	46 (16)
Sex: Female, Male (Count of Participants)
Female	58 38.7%	60 40%	67 44.7%	185 41.1%
Male	89 59.3%	85 56.7%	82 54.7%	256 56.9%
Region of Enrollment (participants) [Number]
United States	147 98%	145 96.7%	149 99.3%	450 100%
OMA Insertion attempts (Count of Participants)
1 attempt	122 81.3%	126 84%	136 90.7%	384 85.3%
2 attempts	21 14%	16 10.7%	12 8%	49 10.9%
3 attempts	3 2%	3 2%	1 0.7%	7 1.6%
4 attempts	1 0.7%	0 0%	0 0%	1 0.2%
OSA insertion time in seconds (Seconds) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Seconds]	54	54	56	55
Duration of OMA device (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	71	65	62	66
BMI (kg/m∧2 ) (BMI (kg/m∧2 )) [Median (Standard Deviation) ]
Median (Standard Deviation) [BMI (kg/m∧2 )]	27.4 (5.2)	27.7 (5.8)	27.8 (5.5)	27.7 (5.6)
Neck Circumference (cm) (centimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [centimeters]	38	38	38	38
Mallampati Class (participants) [Number]
Class I	69 46%	60 40%	64 42.7%	193 42.9%
Class II	39 26%	52 34.7%	49 32.7%	140 31.1%
Class III	20 13.3%	20 13.3%	24 16%	64 14.2%
Class IV	19 12.7%	13 8.7%	12 8%	44 9.8%
ASA physical status (ASA STATUS) [Number]
ASA l	74	70	70	214
ASA ll	67	69	76	212
ASA lll	4	4	3	11
Not documented	2	2	0	4
Surgical Procedure Performed (participants) [Number]
Knee Arthroscopy	95 63.3%	85 56.7%	93 62%	273 60.7%
Shoulder Arthroscopy	29 19.3%	42 28%	41 27.3%	112 24.9%
Elbow Artrhroscopy	8 5.3%	6 4%	5 3.3%	19 4.2%
Other Arthroscopy	7 4.7%	3 2%	1 0.7%	11 2.4%
Breast and skin	2 1.3%	4 2.7%	4 2.7%	10 2.2%
Hernia Repair	3 2%	1 0.7%	3 2%	7 1.6%
Procedure of the eye	3 2%	3 2%	2 1.3%	8 1.8%
Other	0 0%	1 0.7%	0 0%	1 0.2%
Perioperative opioid use (morphine equivalents milligrams) [Median (Inter-Quartile Range) ]
Intraoperative opioid (morEq milligrams)	10	10	10	10
Postoperative opioid (morEq milligrams))	2.7	1.3	1.4	1.4
Total opioid (morEq milligrams)	15	13	13	13
Time to discharge (minutes) [Median (Inter-Quartile Range) ]
Phase 1 immediate PACU (minutes)	67	63	60	63
Phase 2 PACU transition home (minutes)	90	95	95	93
Time to discharge (minutes)	240	236	221	233

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Who Present With Postoperative Sore Throat
Description	The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Measure Participants	147	145	149
Count of Participants [Participants]	71 47.3%	71 47.3%	67 44.7%

2. Primary Outcome

Title	The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Measure Participants	147	145	149
Count of Participants [Participants]	39 26%	31 20.7%	25 16.7%

3. Primary Outcome

Title	The Primary Outcomes for This Study Will be Postoperative Dysphagia.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Measure Participants	147	145	149
Count of Participants [Participants]	45 30%	38 25.3%	34 22.7%

4. Primary Outcome

Title	The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Measure Participants	147	145	149
Count of Participants [Participants]	83 55.3%	80 53.3%	78 52%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Classic, Group 2 Pre Inflated, Group 3 ELL-PIC Technique
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.76
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Severity of Sore Throat
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
Measure Participants	147	145	149
Mean (Inter-Quartile Range) [units on a scale]	143	143	102

6. Secondary Outcome

Title	Blood on LMA After Removal
Description	Presence of blood immediately after the removal of the LMA after surgery.
Time Frame	Immediately after LMA removal

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 Classic	Group 2 Pre Inflated	Group 3 ELL-PIC Technique
Arm/Group Description	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.	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.	Group 3 (ELL-PIC): Using the ELL-PIC technique. Group 3 ELL-PIC Group 3 (ELL-PIC): Using the ELL-PICtechnique
Measure Participants	147	145	149
Count of Participants [Participants]	26 17.3%	24 16%	13 8.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 Classic, Group 2 Pre Inflated, Group 3 ELL-PIC Technique
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.02
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reported p value was calculated.

Adverse Events

Time Frame	24 hours after the airway device removal
Arm/Group Title	Group 1 Classic		Group 2 Pre Inflated		Group 3 ELLIA Technique
Arm/Group Description	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.		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.		Group 3 (ELLIA): Using the ELLIA technique. Group 3 ELLIA: Group 3 (ELLIA): Using the ELLIA technique
All Cause Mortality
	Group 1 Classic		Group 2 Pre Inflated		Group 3 ELLIA Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1 Classic		Group 2 Pre Inflated		Group 3 ELLIA Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/145 (0%)		0/149 (0%)
Other (Not Including Serious) Adverse Events
	Group 1 Classic		Group 2 Pre Inflated		Group 3 ELLIA Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/147 (56.5%)		80/145 (55.2%)		78/149 (52.3%)
Respiratory, thoracic and mediastinal disorders
Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.	83/147 (56.5%)	83	80/145 (55.2%)	80	78/149 (52.3%)	78
Blood on OMA after removal of the OMA	26/147 (17.7%)	26	24/145 (16.6%)	24	13/149 (8.7%)	13

Limitations/Caveats

We did not limit the intracuff pressure of the device, but rather used the manufactures recommended volume in the cuff. . There are no current standard of care guidelines for the ideal intracuff pressures within the oropharngolaryngeal mask airway.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.