CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 432 enrolled
Drug / intervention
laryngeal mask insertiondevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02934243
NCT02934243N/ACompleted

Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

Azienda Ospedaliero-Universitaria Careggi·observational·Posted Oct 14, 2016·Updated Jul 10, 2020

In Brief

An observational study evaluating laryngeal mask insertion for Anesthesia. Completed, enrolled 432 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 14, 2016
Enrollment StartJul 1, 2017
Primary CompletionJul 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.7 years ago

Interventions

laryngeal mask insertiondevice

airway management with laryngeal mask