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This randomized crossover study evaluates the effects of left paratracheal pressure, cricoid pressure, and no pressure on glottic visualization during videolaryngoscopy in adult surgical patients. The primary endpoint is the Percentage of Glottic Opening (POGO) score assessed by blinded video review. Secondary endpoints include anatomical measures (glottic surface area, vertical and horizontal displacement of the glottic plane) and clinical outcomes (first-pass success, first-pass success without desaturation <90%, intubation time, Intubation Difficulty Scale, hypoxemia, hemodynamic events, airway trauma, and postoperative sore throat or dysphonia). All outcomes are collected from routine anesthetic practice and video analysis, with no additional procedures.
This randomized crossover trial will compare three laryngoscopy conditions (no pressure, cricoid pressure, left paratracheal pressure) in adult surgical patients requiring general anesthesia with tracheal intubation. Each patient undergoes all three conditions in random order, with the intubation performed using the maneuver chosen by the operator. Anatomical outcomes (POGO, glottic surface area, vertical and horizontal displacement of the glottic plane) will be assessed from video recordings by blinded evaluators. Clinical outcomes (first-pass success, composite success without desaturation <90%, intubation time, IDS, hypoxemia, hemodynamic changes, airway trauma, sore throat, dysphonia) will be collected from routine anesthetic records and PACU assessments.
Statistical Analysis Plan:
POGO: mixed-effects repeated measures model with patient as random effect, maneuver as fixed effect, adjusted for operator, BMI, and Mallampati.
Anatomical outcomes: analyzed similarly with mixed models and planned contrasts (LPP vs CP).
Clinical outcomes: analyzed as-treated, using logistic or linear regression with adjustments for baseline factors and operator as random effect.
Mediation analysis will evaluate whether improvements in POGO explain clinical benefits (first-pass success, intubation time).
Significance level set at α=0.05 (two-sided), with exploratory outcomes interpreted without multiplicity correction.
Missing data (e.g., unusable videos, missing sore throat scores) will be reported; complete-case analysis will be primary, sensitivity analysis considered if >5% missing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Pressure (Baseline) | No Intervention | Videolaryngoscopy performed without any external laryngeal pressure. This serves as the baseline condition for each patient. | |
| Cricoid Pressure (30 N) | Active Comparator | Videolaryngoscopy performed while applying standardized cricoid pressure (30 N) by a trained operator. A video image is captured during this maneuver. |
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| Left Paratracheal Pressure (30 N) | Experimental | Videolaryngoscopy performed while applying standardized left paratracheal pressure (30 N) by the same operator. A video image is captured during this maneuver. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cricoid Pressure (30 N) | Procedure | Manual application of posterior pressure on the cricoid cartilage at a standardized force of 30 newtons. The pressure is applied by a trained operator using one or two fingers, with the goal of compressing the esophagus against the cervical spine. The maneuver is performed after induction of general anesthesia and immediately before videolaryngoscopy. A still image of the glottic view is captured during pressure application. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Glottic Opening (POGO) score | POGO will be scored from video recordings of each condition (no pressure, cricoid, paratracheal) by blinded assessors (0-100%). | During laryngoscopy, before tracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Glottic surface area | Glottic surface area will be quantified from videolaryngoscopic images under each condition (no pressure, cricoid, paratracheal) using standardized image analysis by blinded reviewers. | During laryngoscopy, before intubation |
| Vertical Displacement of the Glottic Plane |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Javillier, M.D. | Contact | 081209155 | +32 | javillier.benjamin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint-Luc | Bouge | Namur | Belgium |
What: de-identified outcome data (clinical and imaging) and analysis code; selected de-identified video frames. When: after publication. How: upon reasonable request to the sponsor/PI with data-use agreement.
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| ID | Term |
|---|---|
| C054475 | N 30 |
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| Left Paratracheal Pressure (30 N) | Procedure | Manual application of pressure to the left paratracheal region, lateral to the trachea and inferior to the thyroid cartilage, at a standardized force of 30 newtons. The pressure is applied by a trained operator using the thumb or fingers. The maneuver is performed after induction of general anesthesia and immediately before videolaryngoscopy. A still image of the glottic view is captured during pressure application. |
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The vertical shift of the glottic plane relative to baseline will be measured on recorded videolaryngoscopic images under each condition, assessed by blinded reviewers. |
| During laryngoscopy, before intubation |
| Horizontal displacement of the glottic plane | The horizontal (lateral) shift of the glottic plane relative to baseline will be measured on recorded videolaryngoscopic images under each condition, assessed by blinded reviewers. | During laryngoscopy, before intubation |
| First-pass intubation success | Successful tracheal intubation at the first attempt with the maneuver chosen by the operator. | From laryngoscope insertion to first confirmed capnography |
| Time to intubation | Duration in seconds until successful tracheal intubation. | From laryngoscope insertion to first confirmed capnography |
| Intubation Difficulty Scale (IDS) | Composite score including attempts, operators, optimization maneuvers, and force required. | During intubation |
| First-attempt success without desaturation < 90% | Binary composite. Success = both (1) first-attempt intubation (tube placed without complete blade removal; optimizations allowed without blade withdrawal) and (2) no SpO₂ < 90% for ≥ 5 s within the time frame. | From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes. |
| Hypoxemia | Oxygen saturation <92% recorded by pulse oximetry. | From induction until confirmed intubation |
| Hemodynamic events | Systolic blood pressure drop >20% from baseline or heart rate <50/min. | From induction until confirmed intubation |
| Airway trauma | Blood on blade/stylet or visible lip/mucosal injury. | Immediately after intubation |
| Postoperative sore throat | Patient-reported throat pain on numeric scale (0-10). | 30-60 minutes in PACU |