PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)
- Conditions
- Airway Management During General Anesthesia
- Registration Number
- NCT07004998
- Lead Sponsor
- University of Liege
- Brief Summary
This study aims to compare two commonly used external laryngeal pressure techniques-cricoid pressure and left paratracheal pressure-and their effects on the glottic view during videolaryngoscopy in anesthetized patients. Using standardized imaging, the study will assess how each maneuver affects the visibility and position of the vocal cords, as well as the ease of intubation. Each patient will undergo all three conditions (no pressure, cricoid pressure, paratracheal pressure), and the findings may help improve airway management during general anesthesia.
- Detailed Description
During the induction of general anesthesia, external pressure is often applied to the neck to reduce the risk of gastric regurgitation and aspiration. The most widely used technique is cricoid pressure, but it may impair the view of the vocal cords and complicate intubation. An alternative technique-left paratracheal pressure-may provide similar protection of the airway while preserving a better glottic view, but this has not been clearly demonstrated in clinical practice.
This prospective crossover study will include 50 adult patients undergoing elective surgery under general anesthesia. After induction, each patient will undergo videolaryngoscopy under three sequential conditions: no pressure (baseline), cricoid pressure (30 N), and left paratracheal pressure (30 N), with the sequence randomized. For each condition, a standardized image of the vocal cords will be captured using a videolaryngoscope.
The study will compare how each pressure technique affects the visible glottic surface area, the displacement of the glottic plane, and the Percentage of Glottic Opening (POGO). In addition, clinical parameters such as the number of intubation attempts, use of adjunctive maneuvers (e.g., bougie), and total intubation time will be recorded. This study aims to determine whether left paratracheal pressure could be a safer and more effective alternative to cricoid pressure during airway management.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Age ≥ 18 years
- Scheduled for elective surgery under general anesthesia requiring endotracheal intubation
- ASA physical status I or II
- Normal airway anatomy as assessed by the anesthesiologist (Mallampati I-II, no known or anticipated difficult airway)
- Written informed consent obtained prior to inclusion
- History of difficult intubation or anticipated difficult airway
- Known upper airway anatomical abnormalities (e.g., tumors, tracheal deviation, cervical spine instability)
- BMI > 35 kg/m²
- Gastroesophageal reflux disease or increased aspiration risk
- Pregnancy
- Emergency surgery
- Allergy or contraindication to any anesthetic drugs used
- Inability to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Glottic Surface Area During Videolaryngoscopy Under Cricoid and Left Paratracheal Pressure During induction of general anesthesia (within 5 minutes) The visible glottic surface area (in mm²) will be measured using standardized videolaryngoscopic images acquired under three conditions: no external pressure, cricoid pressure (30 N), and left paratracheal pressure (30 N). For each patient, a still image will be captured during each condition, and the surface area will be quantified using calibrated image analysis software. Two independent, blinded assessors will perform the measurements to ensure reproducibility.
- Secondary Outcome Measures
Name Time Method Incidence of Difficult Intubation Under Cricoid and Left Paratracheal Pressure Immediately following induction and intubation (within 10 minutes) Difficult intubation is defined as the occurrence of one or more of the following criteria: (1) more than one intubation attempt, (2) use of adjunctive maneuvers (e.g., bougie, repositioning, pressure release), or (3) total intubation time exceeding 60 seconds. These events will be recorded for each patient immediately following the videolaryngoscopy sequence. The comparison between cricoid and left paratracheal pressure will focus on whether one technique is associated with a higher incidence of difficult intubation.
Vertical Displacement of the Glottic Plane Under External Pressure During induction of general anesthesia (within 5 minutes) Vertical displacement of the glottic plane (in millimeters) will be measured by comparing standardized videolaryngoscopic images obtained under cricoid pressure and left paratracheal pressure. Displacement will be quantified relative to a fixed anatomical reference using image analysis software. Each image will be assessed by two independent blinded raters.
Percentage of Glottic Opening (POGO) Score Under Each Pressure Condition During induction of general anesthesia (within 5 minutes) The Percentage of Glottic Opening (POGO) score will be assigned to each videolaryngoscopic image acquired under no pressure, cricoid pressure, and left paratracheal pressure. POGO is a visual estimate from 0% (no glottic view) to 100% (full view of the glottis), rated by two independent blinded observers.
Total Time to Successful Intubation Immediately after videolaryngoscopy (within 10 minutes) Total intubation time is defined as the time in seconds from the insertion of the videolaryngoscope into the patient's mouth to the confirmation of endotracheal tube placement by capnography. Timing will be performed with a stopwatch by an independent observer.
Number of Intubation Attempts Required Under Each Condition Immediately after videolaryngoscopy (within 10 minutes) The number of attempts required for successful intubation will be recorded for each patient. An attempt is defined as a complete insertion and removal of the videolaryngoscope or endotracheal tube. Only the first intubation attempt will be performed during the study sequence.
Use of Adjunctive Maneuvers During Intubation Immediately after videolaryngoscopy (within 10 minutes) Adjunctive maneuvers include any secondary technique required to facilitate intubation, such as bougie use, removal or modification of pressure, external laryngeal manipulation, or patient repositioning. Each occurrence will be documented by the operator immediately after intubation.
Trial Locations
- Locations (1)
Clinique Saint-Luc
🇧🇪Bouge, Namur, Belgium