Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

July 8, 2020 updated by: Alessandro Di Filippo, Azienda Ospedaliero-Universitaria Careggi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy, 50136
        • Alessandro Di Filippo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive patients submitted to insertion of laryngeal mask collected in 8 Italian research centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
easy Laryngeal Mask insertion
patients in whom the insertion of the SIM has proven easy
Device: laryngeal mask insertion
airway management with laryngeal mask
difficult Laryngeal Mask insertion
patients in whom the insertion of the SIM has proven difficult
Device: laryngeal mask insertion
airway management with laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success in the first attempt
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for 2 or more attempts
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion
Substitution with another LM of different size
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion
Change in strategy (intubation, awakening)
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion
Ventilation difficulties
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion
Movement or swallowing after placement
Time Frame: Immediately after the attempt of insertion
number
Immediately after the attempt of insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Investigators

  • Principal Investigator: Alessandro Di Filippo, Dr, Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GDSAIRWAY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data collected were available for the researchers by direct information and divulgation by principal researcher

IPD Sharing Time Frame

immediately and for the duration of the data collection

IPD Sharing Access Criteria

email by principal researcher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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