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

Tracheal Intubation Morbidity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02671877
• Other study ID #: 132/ INT /2015
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2016
• Last updated: March 2, 2017
• Start date: January 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: IRCCS San Raffaele
• Contact: Marco Gemma, MD
• Phone: 0039 0226432656
• Email: gemma.marco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective, single-center, observational study. Aim of this study is the evaluation of preoperative transnasal fiberoscopy as a predictor of difficult laryngoscopy and intubation during elective general anesthesia in an adult population. Unexpected difficult of failed intubation is a serious, and potentially fatal, occurrence at the induction of general anesthesia. However, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific.

Patients undergoing a scheduled ENT (Ear-Nose-Throat) surgical intervention are subjected to a transnasal fibescopy, a minimally invasive examination, as a part of a normal ENT evaluation before surgery, according to the guidelines of the recruiting center.

During fiberoscopy, the investigators are collecting many anatomical and functional data about the upper airways of the patient. These data include the collapse of the upper airway during the Muller maneuver, the Cormack - Lehane scale as seen in fiberoscopy, the anatomy of the glottis and epiglottis.

The investigators are also collecting data about the preoperative evaluation made by the Anesthesiologist as well as the effective difficulty of laryngoscopy and intubation encountered at the induction of general anaesthesia, expressed by the Cormack - Lehane scale and the Intubation Difficulty Scale (IDS) as described in literature.

General anesthesia will be performed as usual and will not be influenced by fiberoptic evaluation as the Anesthesiologist will be blind to it, and he/she will be free to choose the best anesthesiological plan for his/her patient; whether an elective awake intubation will be chosen, this will exclude the patient from the study.

For safety reasons, the only exception to blindness is an expected difficulty of intubation > 90% (as reported in a VAS scale) by the ENT specialist, based upon the physician's experience. In this case, he will talk to the Anesthesiologist about and the patient will be excluded from the study.

The researchers are excluding from the study patients with suspect or confirmed malignancy of the nose, mouth, pharynx and larynx, as well as patients with trachoestomy, active bleeding lesions or those in which is planned an elective awake intubation for any reason.

To reduce confounders, the fiberoscopy will performed by an ENT specialist chosen in a limited pool (three) and it will be recorded and subsequently reviewed by another one in the same pool. Likewise, general anesthesia will be performed by a limited pool (three) of Anesthesiologists expert in ENT surgery.

Preoperative data obtained by fiberoscopy and intraoperative data recorded by the Anesthesiologist will be matched and analyzed, to explore a possibile relationship.

In literature, this relationship has never been demonstrated nor indagated. If proven, this might give the Anesthestiologist further information about the prediction of a difficult laryngoscopy and intubation, even beyond ENT surgery; in fact, whether fiberoscopy is routinely carried out for surgical reasons (e.g. vascular surgery for the evaluation of recurrent laryngeal nerve prior to aortic surgey) or requested by the Anesthesiologist him/herself at the moment of the preoperative evaluation, it might guide a different - and hopefully safer - anesthesiological strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate to elective ENT surgery under general anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Tracheal Intubation Morbidity

Intervention

Procedure:
• Transnasal fiberoscopy
Minimally invasive exploration ot the upper airways, performed in an awake or minimally sedated patient.

Locations

Country	Name	City	State
Italy	S. Raffaele Hospital	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

Vannucci A, Cavallone LF. Bedside predictors of difficult intubation: a systematic review. Minerva Anestesiol. 2016 Jan;82(1):69-83. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulty of tracheal intubation	The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS).	Intraoperative (single assessment)
Secondary	Difficulty of tracheal laryngoscopy	The difficulty of tracheal laryngoscopy is described with the Cormack - Lehane Scale.	Intraoperative (single assessment)