Postoperative ComplicationsLadyLAMANCT04915534
Gender Specific Differences in Postoperative Sore Throat for Ambu® AuraGain™ Laryngeal Mask
A study testing Ambu® AuraGain™ Laryngeal Mask (LM) in people with Postoperative Complications and Postoperative Pain, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Postoperative Pain
- What is being tested?
- Ambu® AuraGain™ Laryngeal Mask (LM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2021to 30 Aug 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective surgery in ophthalmology under general anaesthesia with laryngeal mask
- Age > 18
- informed written consent
Who cannot join
- Anticipated difficult airway with indication for awake tracheal intubation
- Indication for RSI or elevated risk for aspiration;
- Pregnant or breastfeeding;
- Age < 18 years;
- Obesity
- Out-patient surgery (Geb. 505);
Show all 10Show fewer
- Limited mouth opening;
- Pre-existing hoarseness and sore throat
- Participant in other studies
- Unable to provide informed written consent or under guardianship
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg-University
Mainz, Rhineland-Palatine, 55131
About this study
Official title: Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask
The purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.
Read the detailed description
The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.
- Conditions
- Postoperative Complications, Postoperative Pain
- Being tested
- Ambu® AuraGain™ Laryngeal Mask (LM)
- Keywords
- postoperative sore throat and hoarseness (POST), laryngeal mask
- Medical subject headings
- Postoperative Complications, Pain, Postoperative, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® AuraGain™ Laryngeal Mask (LM)Device
Also called Cuff pressure
Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.
| Study group | Role | What they receive |
|---|---|---|
| Women - low cuff pressure | Other | A cuff pressure of 45 cm H2O is used to block the laryngeal mask Receives: Device: Ambu® AuraGain™ Laryngeal Mask (LM) |
| Men - low cuff pressure | Other | A cuff pressure of 45 cm H2O is used to block the laryngeal mask Receives: Device: Ambu® AuraGain™ Laryngeal Mask (LM) |
| Women - normal cuff pressure | Other | A cuff pressure of 60 cm H2O is used to block the laryngeal mask Receives: Device: Ambu® AuraGain™ Laryngeal Mask (LM) |
| Men - normal cuff pressure | Other | A cuff pressure of 60 cm H2O is used to block the laryngeal mask Receives: Device: Ambu® AuraGain™ Laryngeal Mask (LM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender specific differences in sore throat 24 hours postoperative
Comparing the incidence of postoperative sore throat between males and females within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery
Measured: 24 hours after general anaesthesia (removal of laryngeal mask)
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure
Comparing the incidence of postoperative sore throat within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery in correlation to cuff pressure (45 cmH2O and 60 cmH2O)
Measured: 24 hours after general anaesthesia (removal of laryngeal mask)
Secondary outcomes (1)
Risk factors for postoperative sore throat in correlation to gender and cuff pressure
Evaluating the effect of cuff pressure (45 cmH2O vs 60 cmH2O) stratified by gender on the incidence of postoperative sore throat (%). Furthermore, incidence of postoperative sore throat and hoarseness in PACU, at 48 and 72 hours until freedom of symptoms in correlation to gender and cuff pressure. In addition, influence of gender and cuff pressure on duration of pain and pain quality (measured via a pain scale of 0 = no pain, 1 = less than a cold, 2 = like a cold, 3 = more than a cold) will be evaluated.
Measured: From end of general anaesthesia (removal of laryngeal mask) until at minimum Day 3. If symptoms persist past Day 3 postoperatively, the maximum observation period is 100 days or until freedom of symptoms (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 Dec 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- prospective, randomized, controlled, single-blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Epp, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915534
- Sponsor's protocol ID
- 13715
- Acronym
- LadyLAMA
- Status last verified
- Apr 2024
- First submitted
- 21 May 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaensson M, Gupta A, Nilsson U. Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Jul 19;14:56. doi: 10.1186/1471-2253-14-56. eCollection 2014.
PubMed 25061426Epp K, Przybylski U, Luz C, Kriege M, Wittenmeier E, Schmidtmann I, Pirlich N. Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. BMJ Open. 2022 Jan 31;12(1):e056465. doi: 10.1136/bmjopen-2021-056465.
PubMed 35105650
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gender Specific Differences in Postoperative Sore Throat Following General Anaesthesia With Ambu® AuraGain™ Laryngeal Mask
- ClinicalTrials.gov ID
- NCT04915534
- Acronym / sponsor ID
- LadyLAMA / 13715
- Conditions
- Postoperative Complications, Postoperative Pain
- Keywords
- postoperative sore throat and hoarseness (POST), laryngeal mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Jun 2021 (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 purpose of this study is to evaluate gender specific risk factors and the influence of cuff pressure in the occurrence of postoperative sore throat and hoarseness following general anaesthesia using Ambu® AuraGain™ Laryngeal Mask.
Detailed description
The history and physical examinations of all patients scheduled for surgery are screened preoperatively for exclusion criteria. Patient recruitment is conducted by one of the study physicians. After eligibility is confirmed and written informed consent is obtained, enrolled participants are randomized depending on their gender (400 men, 400 women) in a single-blinded manner (patients) 24 hours before the intervention in a 1:1 ratio to low cuff pressure (45 cmH2O) or normal cuff pressure (60 cmH2O). Patient questioning via questionnaire is conducted in postoperative anaesthetic care unit, 24h, 48h and 72h until freedom of symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- prospective, randomized, controlled, single-blinded
| Arm | Type | Receives |
|---|---|---|
| Women - low cuff pressure | Other | Device: Ambu® AuraGain™ Laryngeal Mask (LM)A cuff pressure of 45 cm H2O is used to block the laryngeal mask |
| Men - low cuff pressure | Other | Device: Ambu® AuraGain™ Laryngeal Mask (LM)A cuff pressure of 45 cm H2O is used to block the laryngeal mask |
| Women - normal cuff pressure | Other | Device: Ambu® AuraGain™ Laryngeal Mask (LM)A cuff pressure of 60 cm H2O is used to block the laryngeal mask |
| Men - normal cuff pressure | Other | Device: Ambu® AuraGain™ Laryngeal Mask (LM)A cuff pressure of 60 cm H2O is used to block the laryngeal mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective surgery in ophthalmology under general anaesthesia with laryngeal mask
- Age > 18
- informed written consent
Key exclusion criteria (10 listed)
- Anticipated difficult airway with indication for awake tracheal intubation
- Indication for RSI or elevated risk for aspiration;
- Pregnant or breastfeeding;
- Age < 18 years;
- Obesity
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 |
|---|---|---|
| Ambu® AuraGain™ Laryngeal Mask (LM)Also: Cuff pressureDepending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness. | Device | Men - low cuff pressure, Men - normal cuff pressure, Women - low cuff pressure, Women - normal cuff pressure |
Primary outcome
Gender specific differences in sore throat 24 hours postoperative
Time frame: 24 hours after general anaesthesia (removal of laryngeal mask)
Comparing the incidence of postoperative sore throat between males and females within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery
Differences in sore throat 24 hours postoperatively in correlation to cuff pressure
Time frame: 24 hours after general anaesthesia (removal of laryngeal mask)
Comparing the incidence of postoperative sore throat within the first 24 hours after general anaesthesia with a second-generation Ambu® AuraGain™ Laryngeal Mask for elective, ophthalmological surgery in correlation to cuff pressure (45 cmH2O and 60 cmH2O)
1 secondary outcome
Risk factors for postoperative sore throat in correlation to gender and cuff pressure
Time frame: From end of general anaesthesia (removal of laryngeal mask) until at minimum Day 3. If symptoms persist past Day 3 postoperatively, the maximum observation period is 100 days or until freedom of symptoms (whichever comes first)
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 16 Apr 2024.
- Background: PubMed 25061426Jaensson M, Gupta A, Nilsson U. Gender differences in sore throat and hoarseness following endotracheal tube or laryngeal mask airway: a prospective study. BMC Anesthesiol. 2014 Jul 19;14:56. doi: 10.1186/1471-2253-14-56. eCollection 2014.
- Derived from this study: PubMed 35105650Epp K, Przybylski U, Luz C, Kriege M, Wittenmeier E, Schmidtmann I, Pirlich N. Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. BMJ Open. 2022 Jan 31;12(1):e056465. doi: 10.1136/bmjopen-2021-056465.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu® AuraGain™ Laryngeal Mask (LM) in people with Postoperative Complications and Postoperative Pain, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 10 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 16 Apr 2024. 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 Germany. 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?
Gender specific differences in sore throat 24 hours postoperative (time frame: 24 hours after general anaesthesia (removal of laryngeal mask)). The study lists 2 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 NCT04915534, which also lists 2 linked publications.
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 16 Apr 2024.