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Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

NCT02934243 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 432

Last updated 2020-07-10

No results posted yet for this study

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.

Conditions

  • Anesthesia

Interventions

DEVICE

laryngeal mask insertion

airway management with laryngeal mask

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Alessandro Di Filippo, Dr · Azienda Ospedaliero-Universitaria Careggi

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-07-01
Completion
2019-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934243 on ClinicalTrials.gov