Clinical trial NCT03341507: Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method
Official title: A Comparative Study Between the Rigid Tube for Laryngoscopy, as a New Tool for Tracheal Intubation, and McIntosh Laryngoscope in Difficult Airway Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: laryngoscopy
retromolar
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A group of patients with difficult airway criteria will be intubated using the rigid tube for laryngoscopy. A classical laryngoscopy with a McIntosh laryngoscope will be performed prior intubation and the Cormack-Lehane grade of glottis visualisation will be noted. If the Cormack -Lehane grade of glotic visualisation 2b, 3 or 4, the intubation maneuvre is carried further with the rigid tube. If the Cormack-Lehane glottic visualisation grade is less than 2b (1 or 2a) the intubation is accomplished with the MacIntosh laryngoscope (conventional laryngoscope) and the patient is excluded from the study from that point further.
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal intubation in patients with presumed difficult airway and compare the classical laryngoscopy and this method in matter of glottis visualisation and tracheal intubation.

Detailed description: The rigid tube for laryngoscopy is a 15 to 30 cm long metallic tube with a bevel end and a diameter of 0.5-2.0 cm , an instrument used to inspect the larynx and surrounding areas. It resembles a rigid bronchoscope but it is shorter. When in use, it has to be attached to a light source.

The hypothesis of the study stands that the rigid tube for laryngoscopy could be more efficient in tracheal intubation for difficult airway patients when the classical intubation with a curved blade laryngoscope is unsatisfactory.

The retromolar approach in both sides together with bougie(intubating tube introducer) intubation is the technique of intubation used in this study.

Eligibility criteria: Inclusion Criteria:

* patients with criteria of anatomically difficult airway from SARI (The Simplified Airway Risk Index Scale) parameters analysis
* patients with airway pathology which predicted difficult intubation: tumors or cervical masses, previous radiotherapy or surgery

Exclusion Criteria:

* stridor or marked laryngeal or tracheal stenosis, vocal cords polyps
* emergency surgery, decompensated cardiac or pulmonary disease
* grade 1 and 2a at classical laryngoscopy after Cormack- Lehane Classification

Primary outcomes:
measure: Time to Tracheal Intubation With the Rigid Tube
timeFrame: 120 seconds
Secondary outcomes:
measure: Complications During Intubation With Rigid Tube
timeFrame: 5 minutes
measure: Late Complications of Intubation With Rigid Tube
timeFrame: 3 days
Other outcomes:
measure: Conventional Laryngoscopy With the Curved Blade Laryngoscope ( MacIntosh) and Tracheal Intubation With the Curved Blade Laryngoscope if the Cormack-Lehane Glottis View Grade is 1 or 2a.
timeFrame: 60 seconds
Locations:
city: Cluj Napoca
country: Romania
facility: Cluj County Emergency Hospital- ENT Clinic
state: Cluj
Study officials:
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu- Cluj Napoca, Romania
name: Ioan Florin Marchis, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norskov AK, Rosenstock CV, Wetterslev J, Lundstrom LH. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. Trials. 2013 Oct 23;14:347. doi: 10.1186/1745-6215-14-347.
citation: Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available.