Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation

NCT02671877 | Unknown

• 1 other identifier: 132/ INT /2015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is the evaluation of preoperative transnasal fiberoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an adult population. Transnasal fibercoscopy is a minimally invasive examination and is routinely performed during ENT evaluation; on the other hand, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific, and an unexpected difficult or failed intubation at the induction of general anesthesia is a seriuos, and potentially fatal, emergency in anesthesia. In literature, a correlation between anatomical and functional parameters highlighted by fiberoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor indagated. If proven, this might give the Anesthestiologist further information about the expected difficulty of laryngoscopy and intubation, guiding a different - and hopefully safer - anesthesiological strategy.

Conditions

Tracheal Intubation Morbidity

Outcome Measures

Primary Outcomes (1)

• Difficulty of tracheal intubation

  The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS).

  Intraoperative (single assessment)

Secondary Outcomes (1)

• Difficulty of tracheal laryngoscopy

  Intraoperative (single assessment)

Interventions

Transnasal fiberoscopy PROCEDURE

Minimally invasive exploration ot the upper airways, performed in an awake or minimally sedated patient.

Eligibility Criteria

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

Study Population

Patients candidate to elective Ear-Nose-Throat (ENT) surgery under general anesthesia

You may qualify if:

• Candidate to elective ENT surgery under general anesthesia

You may not qualify if:

• Subjects with suspect or ascertained malignancy of the nose, mouth, phayrx, or larynx that may interfere with tracheal intubation
• Subjects with tracheostomy
• Subjects with active bleeding or waiting for ENT surgery of bleeding lesions
• Subjects candidate to elective awake intubation

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

S. Raffaele Hospital

Milan, MI, 20132, Italy

RECRUITING

Related Publications (5)

• Heinrich S, Birkholz T, Irouschek A, Ackermann A, Schmidt J. Incidences and predictors of difficult laryngoscopy in adult patients undergoing general anesthesia : a single-center analysis of 102,305 cases. J Anesth. 2013 Dec;27(6):815-21. doi: 10.1007/s00540-013-1650-4. Epub 2013 Jun 9.

  PMID: 23748552 BACKGROUND

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

  PMID: 6507827 BACKGROUND

• Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

  PMID: 9416711 BACKGROUND

• Vannucci A, Cavallone LF. Bedside predictors of difficult intubation: a systematic review. Minerva Anestesiol. 2016 Jan;82(1):69-83. Epub 2015 May 20.

  PMID: 25990431 BACKGROUND

• Gemma M, Buratti L, Di Santo D, Calvi MR, Ravizza A, Bondi S, Bussi M, Beretta L. Pre-operative transnasal endoscopy as a predictor of difficult airway: A prospective cohort study. Eur J Anaesthesiol. 2020 Feb;37(2):98-104. doi: 10.1097/EJA.0000000000001127.

  PMID: 31789897 DERIVED

Study Officials

• Beretta Luigi, Full Professor, MD

  IRCCS San Raffaele Hospital and San Raffaele University, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Gemma, MD

CONTACT

0039 0226432656; gemma.marco@hsr.it

Luca Buratti, MD

CONTACT

0039 0226432656; 14luca14@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: January 23, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)