Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion

NCT02934243 | Completed DMC

• 1 other identifier: GDSAIRWAY
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laryngeal Masks; Ventilation; Risk factors

Outcome Measures

Primary Outcomes (1)

• Success in the first attempt

  number

  Immediately after the attempt of insertion

Secondary Outcomes (5)

• Need for 2 or more attempts

  Immediately after the attempt of insertion

• Substitution with another LM of different size

  Immediately after the attempt of insertion

• Change in strategy (intubation, awakening)

  Immediately after the attempt of insertion

• Ventilation difficulties

  Immediately after the attempt of insertion

• Movement or swallowing after placement

  Immediately after the attempt of insertion

Study Arms (2)

easy Laryngeal Mask insertion

patients in whom the insertion of the SIM has proven easy

Device: laryngeal mask insertion

difficult Laryngeal Mask insertion

patients in whom the insertion of the SIM has proven difficult

Device: laryngeal mask insertion

Interventions

laryngeal mask insertion DEVICE

airway management with laryngeal mask

difficult Laryngeal Mask insertion; easy Laryngeal Mask insertion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Alessandro Di Filippo

Florence, 50136, Italy

Location

Related Publications (12)

• 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.

  PMID: 6349667 BACKGROUND

• White 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.

  PMID: 10781489 BACKGROUND

• 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.

  PMID: 24348297 BACKGROUND

• 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. doi: 10.1007/BF03011075.

  PMID: 8590490 BACKGROUND

• 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. No abstract available.

  PMID: 23364566 BACKGROUND

• 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.

  PMID: 18702752 BACKGROUND

• 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. doi: 10.1097/00000542-200207000-00010.

  PMID: 12131105 BACKGROUND

• Lubarsky 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.

  PMID: 8695119 BACKGROUND

• 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. doi: 10.1097/00000539-199601000-00023.

  PMID: 8712387 BACKGROUND

• 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. doi: 10.1177/0310057X9902700612.

  PMID: 10631418 BACKGROUND

• 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.

  PMID: 26401265 BACKGROUND

• 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.

  PMID: 22510864 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro Di Filippo, Dr

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: immediately and for the duration of the data collection
• Access Criteria: email by principal researcher

Locations

IT (1)