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Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation (TubeDiff)

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ClinicalTrials.gov Identifier: NCT02671877
Recruitment Status : Unknown
Verified March 2017 by Marco Gemma, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : February 2, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Marco Gemma, IRCCS San Raffaele

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.


Condition or disease Intervention/treatment
Tracheal Intubation Morbidity Procedure: Transnasal fiberoscopy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : March 1, 2017

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


Primary Outcome Measures :
  1. Difficulty of tracheal intubation [ Time Frame: Intraoperative (single assessment) ]
    The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS).


Secondary Outcome Measures :
  1. Difficulty of tracheal laryngoscopy [ Time Frame: Intraoperative (single assessment) ]
    The difficulty of tracheal laryngoscopy is described with the Cormack - Lehane Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients candidate to elective Ear-Nose-Throat (ENT) surgery under general anesthesia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671877


Contacts
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Contact: Marco Gemma, MD 0039 0226432656 gemma.marco@hsr.it
Contact: Luca Buratti, MD 0039 0226432656 14luca14@gmail.com

Locations
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Italy
S. Raffaele Hospital Recruiting
Milano, MI, Italy, 20132
Contact: Marco Gemma, MD    ++390226432656    gemma.marco@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Beretta Luigi, Full Professor, MD IRCCS San Raffaele Hospital and San Raffaele University, Milan, Italy
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Gemma, Professor, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT02671877    
Other Study ID Numbers: 132/ INT /2015
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No