Pharyngolaryngeal Postoperative PainDISPOSITIF LARNCT03614598
Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
A study testing Insertion of LMA-UNIQUE(TM) device, Insertion of LMA-SUPREME(TM) device and Insertion of I-GEL(R) device in people with Pharyngolaryngeal Postoperative Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5% Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngolaryngeal Postoperative Pain
- What is being tested?
- Insertion of LMA-UNIQUE(TM) device, Insertion of LMA-SUPREME(TM) device and Insertion of I-GEL(R) device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2009to 6 Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Adult patients > 18
- ASA score I-III
- Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
Show all 18Show fewer
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
- Emergency surgery
- Sore thoat ≤ 1 month
- Risk of aspiration of gastric contents
- Body mass index (BMI) > 35
- Patients with expected airway difficulties
- Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
- Patients who are not fasting for routine and emergency anesthesia
- Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%
- Conditions
- Pharyngolaryngeal Postoperative Pain
- Being tested
- Insertion of LMA-UNIQUE(TM) device, Insertion of LMA-SUPREME(TM) device, Insertion of I-GEL(R) device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of LMA-UNIQUE(TM) deviceProcedure or surgery
LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Insertion of LMA-SUPREME(TM) deviceProcedure or surgery
LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Insertion of I-GEL(R) deviceProcedure or surgery
I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| LMA-UNIQUE™ | Active comparator | Not described Receives: Procedure: Insertion of LMA-UNIQUE(TM) device |
| LMA-SUPREME™ | Active comparator | Not described Receives: Procedure: Insertion of LMA-SUPREME(TM) device |
| I-GEL® | Active comparator | Not described Receives: Procedure: Insertion of I-GEL(R) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pharyngolaryngeal postoperative pain of the three devices
Sore throat Y/N
Measured: 24 hours
Secondary outcomes (10)
Pharyngolaryngeal postoperative pain between groups
Sore throat Y/N
Measured: 2 hours
Time taken to place device
From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds)
Measured: End of surgery (maximum 2 hours)
Number of attempts needed to place device
Measured: End of surgery (maximum 2 hours)
Necessity of altering the size of the device
Y/N
Measured: End of surgery (maximum 2 hours)
Any patient movement during procedure
Y/N
Measured: End of surgery (maximum 2 hours)
Difficulty of insertion
5-point scale: very easy-failure
Measured: End of surgery (maximum 2 hours)
Total leakage pressure of the devices
measured directly by the respirator
Measured: End of surgery (maximum 2 hours)
Ventilatory pressure of the devices
Measured: End of surgery (maximum 2 hours)
Device stability during surgery
Need to change the management system airways (orotracheal intubation or others) Y/N
Measured: End of surgery (maximum 2 hours)
Difficulty of device removal
4-point scale: very easy-very difficult
Measured: End of surgery (maximum 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start22 Apr 2009
- Primary completion5 Sep 2012
- Study completion6 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharyngolaryngeal Postoperative PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joël L'Hermite, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614598
- Sponsor's protocol ID
- Local/2008/JL- 02
- Other IDs
- 2008-A00741-54
- Acronym
- DISPOSITIF LAR
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2018
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539.
PubMed 27755181
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
- ClinicalTrials.gov ID
- NCT03614598
- Acronym / sponsor ID
- DISPOSITIF LAR / Local/2008/JL- 02
- Conditions
- Pharyngolaryngeal Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Apr 2009 (actual)
- Primary completion
- 5 Sep 2012 (actual)
- Study completion
- 6 Sep 2012 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMA-UNIQUE™ | Active comparator | Procedure: Insertion of LMA-UNIQUE(TM) device |
| LMA-SUPREME™ | Active comparator | Procedure: Insertion of LMA-SUPREME(TM) device |
| I-GEL® | Active comparator | Procedure: Insertion of I-GEL(R) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Adult patients > 18
- ASA score I-III
- Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Insertion of LMA-UNIQUE(TM) deviceLMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation | Procedure or surgery | LMA-UNIQUE™ |
| Insertion of LMA-SUPREME(TM) deviceLMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation | Procedure or surgery | LMA-SUPREME™ |
| Insertion of I-GEL(R) deviceI-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation | Procedure or surgery | I-GEL® |
Primary outcome
Incidence of pharyngolaryngeal postoperative pain of the three devices
Time frame: 24 hours
Sore throat Y/N
10 secondary outcomes
Pharyngolaryngeal postoperative pain between groups
Time frame: 2 hours
Time taken to place device
Time frame: End of surgery (maximum 2 hours)
Number of attempts needed to place device
Time frame: End of surgery (maximum 2 hours)
Necessity of altering the size of the device
Time frame: End of surgery (maximum 2 hours)
Any patient movement during procedure
Time frame: End of surgery (maximum 2 hours)
Difficulty of insertion
Time frame: End of surgery (maximum 2 hours)
Total leakage pressure of the devices
Time frame: End of surgery (maximum 2 hours)
Ventilatory pressure of the devices
Time frame: End of surgery (maximum 2 hours)
Device stability during surgery
Time frame: End of surgery (maximum 2 hours)
Difficulty of device removal
Time frame: End of surgery (maximum 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 27755181L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539.
Related trials for Pharyngolaryngeal Postoperative Pain
RecruitingObservational study
Tracheal Cuff Pressure and Postoperative Complications
Tracheal Intubation, Postoperative Complications (Cardiopulmonary)
Recruiting
Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients
Elderly (People Aged 65 or More), LMA
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.
Joël L'Hermite, MD principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of LMA-UNIQUE(TM) device, Insertion of LMA-SUPREME(TM) device and Insertion of I-GEL(R) device in people with Pharyngolaryngeal Postoperative Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 18 inclusion and 0 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 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of pharyngolaryngeal postoperative pain of the three devices (time frame: 24 hours). 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 NCT03614598, 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 Nov 2025.