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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laryngoscopy and tracheal intubation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| classical laryngoscopy | Device | the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications During Intubation With Rigid Tube | complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80% | 5 minutes |
| Late Complications of Intubation With Rigid Tube |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioan Florin Marchis, Md | University of Medicine and Pharmacy Iuliu Hatieganu- Cluj Napoca, Romania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cluj County Emergency Hospital- ENT Clinic | Cluj-Napoca | Cluj | 400006 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24152537 | Background | 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. | |
| 9349093 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laryngoscopy and Tracheal Intubation | 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. 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 if the Cormack -Lehane glottis view is 2b,3 or 4 during conventional laryngoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with difficult airway criteria according to SARI score schedulled for ear nose and throat (ENT) surgery under general anesthesia and tracheal intubation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | seconds | 120 seconds |
|
complications noticed during and following the use of rigid tube : time frame-3 days
Complications during intervention- hypoxia, cardiac rhythm disturbances, hypertension, cardiac arrest, bronchospasm.
Patient assessment after anesthesia for sore throat, voice disturbances, bleeding, teeth and soft tissue injury, neurological disorders following intervention, coughing, shortness of breath or chest pain
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laryngoscopy and Tracheal Intubation | 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. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | hypoxia during airway management |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | complaint of sore throat after general anesthesia and tracheal intubation |
This is an observational single-center study that relies on personal perception and the skill of a limited number of investigators. To master the rigid tube a period of training and regular use is needed.
The major disadvantage of the rigid tube for laryngoscopy is the reduced visual field which can be improved by increasing the tube diameter. The bougie intubation carries the risk of vocal cords injury and impossibility of advancing the tracheal tube if the respiratory space is too narrow.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ioan Florin Marchis | Iuliu Hatieganu University of Medicine and Pharmacy- Cluj Napoca Romania | +40757065205 | 0757065205 | marchis.ioan@umfcluj.ro |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2017 | Oct 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007828 | Laryngoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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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.
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|
| rigid tube for laryngoscopy | Device | the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed |
|
complications noticed following the use of rigid tube - sore throat, upper lip injury.
| 3 days |
| 60 seconds |
| Rutter JM, Murphy PG. Cormack and Lehane revisited. Anaesthesia. 1997 Sep;52(9):927. No abstract available. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| The Simplified Airway Risk Index Scale(SARI) score ≥ 5. | The Simplified Airway Risk Index (or SARI) is a multivariate risk score for predicting difficult tracheal intubation. The SARI score ranges from 0 to 12 points, where a higher number of points indicates a more difficult airway. A SARI score of 4 or above indicate a difficult intubation. Seven parameters are used to calculate the SARI score: Mouth opening, thyromental distance, Mallampati score, movement of the neck, the ability to create an underbite, body weight and previous intubation history. | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Secondary | Complications During Intubation With Rigid Tube | complications noticed during the use of rigid tube - hypoxia defined as oxygen saturation less than 80% | 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. | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Late Complications of Intubation With Rigid Tube | complications noticed following the use of rigid tube - sore throat, upper lip injury. | 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. | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 60 seconds |
|
|
|
| 0 |
| 64 |
| 1 |
| 64 |
| 5 |
| 64 |
|
|
| upper lip injury | Skin and subcutaneous tissue disorders | Non-systematic Assessment | upper lip small lesion after rigid tube intubation |
|
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| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |