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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

Tracking Information
First Submitted Date January 23, 2016
First Posted Date February 2, 2016
Last Update Posted Date March 3, 2017
Study Start Date January 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2016)
Difficulty of tracheal intubation [ Time Frame: Intraoperative (single assessment) ]
The difficulty of intubation is described with and the Intubation Difficulty Scale (IDS).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2016)
Difficulty of tracheal laryngoscopy [ Time Frame: Intraoperative (single assessment) ]
The difficulty of tracheal laryngoscopy is described with the Cormack - Lehane Scale.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation
Official Title Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients candidate to elective Ear-Nose-Throat (ENT) surgery under general anesthesia
Condition Tracheal Intubation Morbidity
Intervention Procedure: Transnasal fiberoscopy
Minimally invasive exploration ot the upper airways, performed in an awake or minimally sedated patient.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 29, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671877
Other Study ID Numbers 132/ INT /2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marco Gemma, IRCCS San Raffaele
Study Sponsor IRCCS San Raffaele
Collaborators Not Provided
Investigators
Principal Investigator: Beretta Luigi, Full Professor, MD IRCCS San Raffaele Hospital and San Raffaele University, Milan, Italy
PRS Account IRCCS San Raffaele
Verification Date March 2017