AnesthesiaNCT02934243
Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion
An observational study of Anesthesia, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of complications there may be situations where it is difficult to insert. Therefore it seems appropriate to carry out a prospective observational study that will identify the risk factors relating to the positioning of LM for the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- laryngeal mask insertion
- Type of treatment
- Medical device
- How many people
- 432 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 1 Dec 2019
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients submitted to insertion of laryngeal mask collected in 8 Italian research centers
Who may be able to join
- ASA classification I-II
- Age between 18 and 65 years
- Airway management with laryngeal mask
- Signed informed consent to the study in the medical record
Who cannot join
- Diseases of the upper airways
- Risk of inhalation of gastric contents (previous gastric surgery, hiatal hernia, gastroesophageal reflux, peptic ulcer, stomach full, pregnancy)
- Large obese (BMI> 40)
- Sore throat, voice alteration
- A history of difficult intubation
- Intervention lasting more than 4 hours
Trial locations and contacts
1 site in 1 country.
About this study
Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of complications there may be situations where it is difficult to insert.
Therefore it seems appropriate to carry out a prospective observational study that will identify the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
Read more
From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, must be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
Read the detailed description
Backgrounds Since its introduction into clinical practice in 1983, the laryngeal mask (LM) has found a role in the daily practice of anesthesiologists, including its use as a primary device in the airway management in both elective and emergency and as an emergency approach to the management of difficult airways.
Moreover, the insertion of the LM has become a common technique in the management of the airway, in particular outpatient surgery, where it is associated with a shorter recovery time, faster discharge and thus with a reduction of costs.
Even if the LM is considered a device very safe with a low incidence of complications, there may be situations where it is difficult to insert.
Aim of the study Some studies have concerned the causes that determine the difficulty in the insertion of an LM. They are retrospective studies and/or focused on the analysis of a single type of device.
Therefore, it seems appropriate to carry out a prospective observational study that will identify and weight the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
Methods From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care SIAARTI) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
The centers will be selected based on the fact that between the researchers is including an anesthesiologist part of the Working Group "Airway management" of SIAARTI to act as supervisor.
Statistic Descriptive: for each quantitative variable will be reported mean, standard deviation, first and third quartiles, median, minimum and maximum. For each qualitative variable will be reported frequency and percentage of each category.
Explorative: The association between each risk factor and the proportion of incorrect insertion will be evaluated only in a univariate analysis, using the relative risk and its confidence interval.
Sample size: For a hypothesis test on the relative risk so specified H0: RR ≤ 1 H1: RR> 1 and considering an expected relative risk of 2, a proportion of 2.9% of the failures in the group of experts and a first type error equal to 5%, 832 patients per group are needed to ensure a power equal to 90%.
The limit of significance is set at 5%.
Expected results To calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, can be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
- Conditions
- Anesthesia
- Being tested
- laryngeal mask insertion
- Keywords
- Laryngeal Masks, Ventilation, Risk factors
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal mask insertionDevice
airway management with laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| easy Laryngeal Mask insertion | patients in whom the insertion of the SIM has proven easy Receives: Device: laryngeal mask insertion | |
| difficult Laryngeal Mask insertion | patients in whom the insertion of the SIM has proven difficult Receives: Device: laryngeal mask insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in the first attempt
number
Measured: Immediately after the attempt of insertion
Secondary outcomes (5)
Need for 2 or more attempts
number
Measured: Immediately after the attempt of insertion
Substitution with another LM of different size
number
Measured: Immediately after the attempt of insertion
Change in strategy (intubation, awakening)
number
Measured: Immediately after the attempt of insertion
Ventilation difficulties
number
Measured: Immediately after the attempt of insertion
Movement or swallowing after placement
number
Measured: Immediately after the attempt of insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Di Filippo, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Alessandro Di Filippo, Dr, Principal investigator, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934243
- Sponsor's protocol ID
- GDSAIRWAY
- Status last verified
- Dec 2019
- First submitted
- 13 Oct 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data collected were available for the researchers by direct information and divulgation by principal researcher
Publications
Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
PubMed 6349667White PF. Ambulatory anesthesia advances into the new millennium. Anesth Analg. 2000 May;90(5):1234-5. doi: 10.1097/00000539-200005000-00047. No abstract available.
PubMed 10781489Suhitharan T, Teoh WH. Use of extraglottic airways in patients undergoing ambulatory laparoscopic surgery without the need for tracheal intubation. Saudi J Anaesth. 2013 Oct;7(4):436-41. doi: 10.4103/1658-354X.121081.
PubMed 24348297Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth. 1995 Nov;42(11):1017-23. doi: 10.1007/BF03011075.
PubMed 8590490Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PubMed 23364566Berlac P, Hyldmo PK, Kongstad P, Kurola J, Nakstad AR, Sandberg M; Scandinavian Society for Anesthesiology and Intensive Care Medicine. Pre-hospital airway management: guidelines from a task force from the Scandinavian Society for Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2008 Aug;52(7):897-907. doi: 10.1111/j.1399-6576.2008.01673.x.
PubMed 18702752Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
PubMed 12131105Lubarsky DA. Fast track in the postanesthesia care unit: unlimited possibilities? J Clin Anesth. 1996 May;8(3 Suppl):70S-72S. doi: 10.1016/s0952-8180(96)90016-1. No abstract available.
PubMed 8695119Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.
PubMed 8712387Buckham M, Brooker M, Brimacombe J, Keller C. A comparison of the reinforced and standard laryngeal mask airway: ease of insertion and the influence of head and neck position on oropharyngeal leak pressure and intracuff pressure. Anaesth Intensive Care. 1999 Dec;27(6):628-31. doi: 10.1177/0310057X9902700612.
PubMed 10631418Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
PubMed 26401265Ramachandran SK, Mathis MR, Tremper KK, Shanks AM, Kheterpal S. Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique: a study of 15,795 patients. Anesthesiology. 2012 Jun;116(6):1217-26. doi: 10.1097/ALN.0b013e318255e6ab.
PubMed 22510864
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion
- ClinicalTrials.gov ID
- NCT02934243
- Acronym / sponsor ID
- GDSAIRWAY
- Conditions
- Anesthesia
- Keywords
- Laryngeal Masks, Ventilation, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of complications there may be situations where it is difficult to insert.
Therefore it seems appropriate to carry out a prospective observational study that will identify the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, must be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
Detailed description
Backgrounds Since its introduction into clinical practice in 1983, the laryngeal mask (LM) has found a role in the daily practice of anesthesiologists, including its use as a primary device in the airway management in both elective and emergency and as an emergency approach to the management of difficult airways.
Moreover, the insertion of the LM has become a common technique in the management of the airway, in particular outpatient surgery, where it is associated with a shorter recovery time, faster discharge and thus with a reduction of costs.
Even if the LM is considered a device very safe with a low incidence of complications, there may be situations where it is difficult to insert.
Aim of the study Some studies have concerned the causes that determine the difficulty in the insertion of an LM. They are retrospective studies and/or focused on the analysis of a single type of device.
Therefore, it seems appropriate to carry out a prospective observational study that will identify and weight the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
Methods From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care SIAARTI) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
The centers will be selected based on the fact that between the researchers is including an anesthesiologist part of the Working Group "Airway management" of SIAARTI to act as supervisor.
Statistic Descriptive: for each quantitative variable will be reported mean, standard deviation, first and third quartiles, median, minimum and maximum. For each qualitative variable will be reported frequency and percentage of each category.
Explorative: The association between each risk factor and the proportion of incorrect insertion will be evaluated only in a univariate analysis, using the relative risk and its confidence interval.
Sample size: For a hypothesis test on the relative risk so specified H0: RR ≤ 1 H1: RR> 1 and considering an expected relative risk of 2, a proportion of 2.9% of the failures in the group of experts and a first type error equal to 5%, 832 patients per group are needed to ensure a power equal to 90%.
The limit of significance is set at 5%.
Expected results To calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, can be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| easy Laryngeal Mask insertion | – | Device: laryngeal mask insertionpatients in whom the insertion of the SIM has proven easy |
| difficult Laryngeal Mask insertion | – | Device: laryngeal mask insertionpatients in whom the insertion of the SIM has proven difficult |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients submitted to insertion of laryngeal mask collected in 8 Italian research centers
Key inclusion criteria (4 listed)
- ASA classification I-II
- Age between 18 and 65 years
- Airway management with laryngeal mask
- Signed informed consent to the study in the medical record
Key exclusion criteria (6 listed)
- Diseases of the upper airways
- Risk of inhalation of gastric contents (previous gastric surgery, hiatal hernia, gastroesophageal reflux, peptic ulcer, stomach full, pregnancy)
- Large obese (BMI> 40)
- Sore throat, voice alteration
- A history of difficult intubation
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 |
|---|---|---|
| laryngeal mask insertionairway management with laryngeal mask | Device | difficult Laryngeal Mask insertion, easy Laryngeal Mask insertion |
Primary outcome
Success in the first attempt
Time frame: Immediately after the attempt of insertion
number
5 secondary outcomes
Need for 2 or more attempts
Time frame: Immediately after the attempt of insertion
Substitution with another LM of different size
Time frame: Immediately after the attempt of insertion
Change in strategy (intubation, awakening)
Time frame: Immediately after the attempt of insertion
Ventilation difficulties
Time frame: Immediately after the attempt of insertion
Movement or swallowing after placement
Time frame: Immediately after the attempt of insertion
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 10 Jul 2020.
- Background: PubMed 6349667Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
- Background: PubMed 10781489White PF. Ambulatory anesthesia advances into the new millennium. Anesth Analg. 2000 May;90(5):1234-5. doi: 10.1097/00000539-200005000-00047. No abstract available.
- Background: PubMed 24348297Suhitharan T, Teoh WH. Use of extraglottic airways in patients undergoing ambulatory laparoscopic surgery without the need for tracheal intubation. Saudi J Anaesth. 2013 Oct;7(4):436-41. doi: 10.4103/1658-354X.121081.
- Background: PubMed 8590490Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth. 1995 Nov;42(11):1017-23. doi: 10.1007/BF03011075.
- Background: PubMed 23364566Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Background: PubMed 18702752Berlac P, Hyldmo PK, Kongstad P, Kurola J, Nakstad AR, Sandberg M; Scandinavian Society for Anesthesiology and Intensive Care Medicine. Pre-hospital airway management: guidelines from a task force from the Scandinavian Society for Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2008 Aug;52(7):897-907. doi: 10.1111/j.1399-6576.2008.01673.x.
- Background: PubMed 12131105Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
- Background: PubMed 8695119Lubarsky DA. Fast track in the postanesthesia care unit: unlimited possibilities? J Clin Anesth. 1996 May;8(3 Suppl):70S-72S. doi: 10.1016/s0952-8180(96)90016-1. No abstract available.
- Background: PubMed 8712387Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.
- Background: PubMed 10631418Buckham M, Brooker M, Brimacombe J, Keller C. A comparison of the reinforced and standard laryngeal mask airway: ease of insertion and the influence of head and neck position on oropharyngeal leak pressure and intracuff pressure. Anaesth Intensive Care. 1999 Dec;27(6):628-31. doi: 10.1177/0310057X9902700612.
- Background: PubMed 26401265Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
- Background: PubMed 22510864Ramachandran SK, Mathis MR, Tremper KK, Shanks AM, Kheterpal S. Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique: a study of 15,795 patients. Anesthesiology. 2012 Jun;116(6):1217-26. doi: 10.1097/ALN.0b013e318255e6ab.
- Individual participant dataSharing planned: Yes. All data collected were available for the researchers by direct information and divulgation by principal researcher
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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.
Alessandro Di Filippo, Dr principal investigator
Azienda Ospedaliero-Universitaria Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 4 inclusion and 6 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 10 Jul 2020. 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 Italy. 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?
Success in the first attempt (time frame: Immediately after the attempt of insertion). 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 NCT02934243, which also lists 12 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 10 Jul 2020.