Tracheal Intubation With the Rigid Tube for Laryngoscopy- a New Method

Intubation;Difficult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341507
• Other study ID #: MIFlorin
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 7, 2019

Study information

• Verified date: March 2021
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 7, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• classical laryngoscopy
the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.
• rigid tube for laryngoscopy
the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed

Locations

Country	Name	City	State
Romania	Cluj County Emergency Hospital- ENT Clinic	Cluj Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (2)

Nørskov AK, Rosenstock CV, Wetterslev J, Lundstrøm 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. — View Citation

Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Conventional laryngoscopy was performed with a MacIntosh curved blade laryngoscope, and the Cormack-Lehane grade of glottic visualization was registered. If the grade of glottis view according to Cormack-Lehane classification was less than 2b the patient was intubated using the curved blade laryngoscope. If the grade of glottic view was equal or more than 2b the tracheal intubation was carried further with the rigid tube.	60 seconds
Primary	Time to Tracheal Intubation With the Rigid Tube	the time from starting to use the rigid tube for laryngoscopy until the airway was secured.	120 seconds
Secondary	Complications During Intubation With Rigid Tube	complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%	5 minutes
Secondary	Late Complications of Intubation With Rigid Tube	complications noticed following the use of rigid tube - sore throat, upper lip injury.	3 days