An interventional study of classical laryngoscopy and rigid tube for laryngoscopy in Intubation;Difficult, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Completed at 1 site in Romania. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Tracheal intubation with the rigid tube for laryngoscopy for patients with difficult airway. Prior the use of rigid tube for laryngoscopy, a classical laryngoscopy with a McIntosh laryngoscope will be performed.
Device: classical laryngoscopy · Device: rigid tube for laryngoscopy
the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.
Also known as: laryngoscopy with McIntosh curved blade laryngoscope
the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Time to Tracheal Intubation With the Rigid Tube
the time from starting to use the rigid tube for laryngoscopy until the airway was secured.
Time frame: 120 seconds
Complications During Intubation With Rigid Tube
complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%
Time frame: 5 minutes
Late Complications of Intubation With Rigid Tube
complications noticed following the use of rigid tube - sore throat, upper lip injury.
Time frame: 3 days
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.
Time frame: 60 seconds
| Milestone | Laryngoscopy and Tracheal Intubation |
|---|---|
| Started | 64 |
| Completed | 30 |
| Not completed | 34 |
| Withdrew: Cormack-lehane grade 1 or 2a during conventional laryngoscopy | 34 |
the time from starting to use the rigid tube for laryngoscopy until the airway was secured.
| seconds | Laryngoscopy and Tracheal Intubation |
|---|---|
| Time to Tracheal Intubation With the Rigid Tube | 50.5 (38 to 67) |
complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80%
| Participants | Laryngoscopy and Tracheal Intubation |
|---|---|
| Complications During Intubation With Rigid Tube | 1 |
complications noticed following the use of rigid tube - sore throat, upper lip injury.
| Participants | Laryngoscopy and Tracheal Intubation |
|---|---|
| Late Complications of Intubation With Rigid Tube | 8 |
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.
| Participants | Laryngoscopy and Tracheal Intubation |
|---|---|
| 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. | 34 |
Collected over complications noticed during and following the use of rigid tube : time frame-3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laryngoscopy and Tracheal Intubation | 0/64 (0%) | 1/64 (1.6%) | 5/64 (7.8%) |
| Event | Laryngoscopy and Tracheal Intubation |
|---|---|
| hypoxiaRespiratory, thoracic and mediastinal disorders | 1/64 |
| Event | Laryngoscopy and Tracheal Intubation |
|---|---|
| sore throatRespiratory, thoracic and mediastinal disorders | 5/30 |
| upper lip injurySkin and subcutaneous tissue disorders | 3/30 |
Patients with difficult airway criteria according to SARI score schedulled for ear nose and throat (ENT) surgery under general anesthesia and tracheal intubation.
| Age, Continuous(years) | Tracheal Intubation With the Rigid Tube for Laryngoscopy |
|---|---|
| Mean | 47.8 ± 10.5 |
| Sex: Female, Male(Participants) | Tracheal Intubation With the Rigid Tube for Laryngoscopy |
|---|---|
| Female | 8 |
| Male | 56 |
| Race (NIH/OMB)(Participants) | Tracheal Intubation With the Rigid Tube for Laryngoscopy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 64 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| The Simplified Airway Risk Index Scale(SARI) score ≥ 5.(units on a scale) | Tracheal Intubation With the Rigid Tube for Laryngoscopy |
|---|---|
| Median | 6 (5 to 7) |
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Iuliu Hatieganu University of Medicine and Pharmacy