Clinical trial NCT07004998: PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)
Official title: Comparison of Cricoid and Left Paratracheal Pressure on Glottic View and Intubation Conditions: A Randomized Crossover Trial Using Videolaryngoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Management
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glottic Surface Area During Videolaryngoscopy Under Cricoid and Left Paratracheal Pressure
timeFrame: During induction of general anesthesia (within 5 minutes)
Secondary outcomes:
measure: Incidence of Difficult Intubation Under Cricoid and Left Paratracheal Pressure
timeFrame: Immediately following induction and intubation (within 10 minutes)
measure: Vertical Displacement of the Glottic Plane Under External Pressure
timeFrame: During induction of general anesthesia (within 5 minutes)
measure: Percentage of Glottic Opening (POGO) Score Under Each Pressure Condition
timeFrame: During induction of general anesthesia (within 5 minutes)
measure: Total Time to Successful Intubation
timeFrame: Immediately after videolaryngoscopy (within 10 minutes)
measure: Number of Intubation Attempts Required Under Each Condition
timeFrame: Immediately after videolaryngoscopy (within 10 minutes)
measure: Use of Adjunctive Maneuvers During Intubation
timeFrame: Immediately after videolaryngoscopy (within 10 minutes)
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc
state: Namur
Study officials:
References: