Intubation;Difficult
Conditions
Keywords
laryngoscopy, retromolar
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.
Interventions
DEVICEclassical laryngoscopy
the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.
DEVICErigid tube for laryngoscopy
the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tracheal Intubation With the Rigid Tube | 120 seconds | the time from starting to use the rigid tube for laryngoscopy until the airway was secured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications During Intubation With Rigid Tube | 5 minutes | complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80% |
| Late Complications of Intubation With Rigid Tube | 3 days | complications noticed following the use of rigid tube - sore throat, upper lip injury. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | 60 seconds | 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. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tracheal Intubation With the Rigid Tube for Laryngoscopy The study involved adult patients with ASA physical status 1-3, requiring surgery for an ENT pathology and having a presumed anatomically difficult airway according to The Simplified Airway Risk Index (SARI) score . Signed informed consent was obtained from all patients. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Cormack-Lehane grade 1 or 2a during conventional laryngoscopy | 34 |
Baseline characteristics
| Characteristic | Tracheal Intubation With the Rigid Tube for Laryngoscopy |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 56 Participants |
| The Simplified Airway Risk Index Scale(SARI) score ≥ 5. | 6 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 5 / 64 |
| serious Total, serious adverse events | 1 / 64 |
Outcome results
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.
Time frame: 120 seconds
Population: Patients with a Cormack-Lehane grade 2b,3 or 4 during conventional laryngoscopy who had their airways secured with a rigid tube. Patients with a a Cormack-Lehane grade 1 and 2a were intubated with the curved blade laryngoscope and they were not included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laryngoscopy and Tracheal Intubation | Time to Tracheal Intubation With the Rigid Tube | 50.5 seconds |
Secondary
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
Population: Patients with a Cormack-Lehane grade 2b,3 or 4 during conventional laryngoscopy who had their airways secured with a rigid tube. Patients with a a Cormack-Lehane grade 1 and 2a were intubated with the curved blade laryngoscope and they were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laryngoscopy and Tracheal Intubation | Complications During Intubation With Rigid Tube | 1 Participants |
Secondary
Late Complications of Intubation With Rigid Tube
complications noticed following the use of rigid tube - sore throat, upper lip injury.
Time frame: 3 days
Population: Patients with a Cormack-Lehane grade 2b,3 or 4 during conventional laryngoscopy who had their airways secured with a rigid tube. Patients with a a Cormack-Lehane grade 1 and 2a were intubated with the curved blade laryngoscope and they were not included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laryngoscopy and Tracheal Intubation | Late Complications of Intubation With Rigid Tube | 8 Participants |
Other Pre-specified
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
Population: Conventional laryngoscopy was performed with a MacIntosh curved blade laryngoscope, and the Cormack-Lehane grade of glottis 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 glottis view was equal or more than 2b the tracheal intubation was carried further with the rigid tube.
| Arm | Measure | Value (COUNT_OF_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 Participants |