Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

Anesthesia Clinical Trial

Official title:

Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934243
• Other study ID #: GDSAIRWAY
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• laryngeal mask insertion
airway management with laryngeal mask

Locations

Country	Name	City	State
Italy	Alessandro Di Filippo	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Apfelbaum 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. — View Citation

Apfelbaum 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. — View Citation

Berlac 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. — View Citation

Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. — View Citation

Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth. 1995 Nov;42(11):1017-23. — View Citation

Buckham 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. — View Citation

Katsiampoura 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. — View Citation

Lubarsky DA. Fast track in the postanesthesia care unit: unlimited possibilities? J Clin Anesth. 1996 May;8(3 Suppl):70S-72S. — View Citation

Ramachandran 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. — View Citation

Suhitharan 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. — View Citation

Verghese 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. — View Citation

White PF. Ambulatory anesthesia advances into the new millennium. Anesth Analg. 2000 May;90(5):1234-5. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in the first attempt	number	Immediately after the attempt of insertion
Secondary	Need for 2 or more attempts	number	Immediately after the attempt of insertion
Secondary	Substitution with another LM of different size	number	Immediately after the attempt of insertion
Secondary	Change in strategy (intubation, awakening)	number	Immediately after the attempt of insertion
Secondary	Ventilation difficulties	number	Immediately after the attempt of insertion
Secondary	Movement or swallowing after placement	number	Immediately after the attempt of insertion