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Tracheal Intubation MorbidityTubeDiffNCT02671877

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

An observational study of Tracheal Intubation Morbidity, run by IRCCS San Raffaele at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheal Intubation Morbidity
What is being tested?
Transnasal fiberoscopy
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteItaly
Study dates
Jan 2016to 1 Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Candidate to elective ENT surgery under general anesthesia

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Marco Gemma, MD contact

0039 0226432656

gemma.marco@hsr.it

Luca Buratti, MD contact

0039 0226432656

14luca14@gmail.com

Italy1 site, 1 recruiting
  • S. Raffaele Hospital

    Milan, MI, 20132

    Marco Gemma, MD, ++390226432656, gemma.marco@hsr.it

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Read the 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.

Being tested
Transnasal fiberoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transnasal fiberoscopyProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difficulty of tracheal intubation

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

    Measured: Intraoperative (single assessment)

Secondary outcomes (1)
  1. Difficulty of tracheal laryngoscopy

    The difficulty of tracheal laryngoscopy is described with the Cormack - Lehane Scale.

    Measured: Intraoperative (single assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2016
  4. Study completion1 Mar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02671877
Sponsor's protocol ID
132/ INT /2015
Acronym
TubeDiff
Status last verified
Mar 2017
First submitted
23 Jan 2016
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23748552
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PubMed 6507827
  • 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.

    PubMed 9416711
  • Vannucci A, Cavallone LF. Bedside predictors of difficult intubation: a systematic review. Minerva Anestesiol. 2016 Jan;82(1):69-83. Epub 2015 May 20.

    PubMed 25990431
  • 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.

    PubMed 31789897

Questions about this trial

What is this clinical trial studying?

An observational study of Tracheal Intubation Morbidity, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marco Gemma, MD (0039 0226432656, gemma.marco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difficulty of tracheal intubation (time frame: Intraoperative (single assessment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02671877, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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