Airway MorbidityNCT01749033
A New Insertion Technique for Laryngeal Mask Airway
A study testing Group 1 Classic, Group 2 pre-inflated and Group 3 ELL-PIC in people with Airway Morbidity, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Group 1 Classic, Group 2 pre-inflated and Group 3 ELL-PIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Small mouth opening
- Preoperative sore throat/dysphagia/dysphonia
- Patients at increased risk for aspiration
- Morbid obesity BMI > 40
- Untreated chronic GERD
- Pregnancy
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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.
Read the 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.
- Conditions
- Airway Morbidity
- Being tested
- Group 1 Classic, Group 2 pre-inflated, Group 3 ELL-PIC
- Keywords
- Intubation, Airway, Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 ClassicOther
Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 2 pre-inflatedOther
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.
Group 3 ELL-PICOther
Group 3 (ELL-PIC): Using the ELL-PIC technique
| Study group | Role | What they receive |
|---|---|---|
| Group 1 classic | Active comparator | Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual. Receives: Other: Group 1 Classic |
| Group 2 pre inflated | Active comparator | 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 Receives: Other: Group 2 pre-inflated |
| Group 3 ELL-PIC technique | Active comparator | Group 3 (ELL-PIC): Using the ELL-PIC technique. Receives: Other: Group 3 ELL-PIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
Secondary outcomes (2)
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)
Measured: 24 hours
Blood on LMA After Removal
Presence of blood immediately after the removal of the LMA after surgery.
Measured: Immediately after LMA removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Walega, Northwestern University
- Investigators
- David Walega, MD, Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749033
- Sponsor's protocol ID
- STU00046964
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2012
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hu LQ, Leavitt OS, Malwitz C, Kim H, Doty RA Jr, McCarthy RJ. Comparison of laryngeal mask airway insertion methods, including the external larynx lift with pre-inflated cuff, on postoperative pharyngolaryngeal complications: A randomised clinical trial. Eur J Anaesthesiol. 2017 Jul;34(7):448-455. doi: 10.1097/EJA.0000000000000650.
PubMed 28590309
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Insertion Technique for Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT01749033
- Acronym / sponsor ID
- STU00046964
- Conditions
- Airway Morbidity
- Keywords
- Intubation, Airway, Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 classic | Active comparator | Other: Group 1 ClassicGroup 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual. |
| Group 2 pre inflated | Active comparator | Other: Group 2 pre-inflatedGroup 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer |
| Group 3 ELL-PIC technique | Active comparator | Other: Group 3 ELL-PICGroup 3 (ELL-PIC): Using the ELL-PIC technique. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Small mouth opening
- Preoperative sore throat/dysphagia/dysphonia
- Patients at increased risk for aspiration
- Morbid obesity BMI > 40
- Untreated chronic GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 ClassicActive Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual. | Other | Group 1 classic |
| Group 2 pre-inflatedGroup 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 3 ELL-PICGroup 3 (ELL-PIC): Using the ELL-PIC technique | Other | Group 3 ELL-PIC technique |
Primary outcome
Number of Subjects Who Present With Postoperative Sore Throat
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.
2 secondary outcomes
Severity of Sore Throat
Time frame: 24 hours
Blood on LMA After Removal
Time frame: Immediately after LMA removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28590309Hu LQ, Leavitt OS, Malwitz C, Kim H, Doty RA Jr, McCarthy RJ. Comparison of laryngeal mask airway insertion methods, including the external larynx lift with pre-inflated cuff, on postoperative pharyngolaryngeal complications: A randomised clinical trial. Eur J Anaesthesiol. 2017 Jul;34(7):448-455. doi: 10.1097/EJA.0000000000000650.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Walega, MD study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Classic, Group 2 pre-inflated and Group 3 ELL-PIC in people with Airway Morbidity, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Present With Postoperative Sore Throat (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01749033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.