PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)

NCT07004998 | Not Yet Recruiting DMC

• 1 other identifier: PARAGLIDE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Glottic surface area

  During laryngoscopy, before intubation

• Vertical Displacement of the Glottic Plane

  During laryngoscopy, before intubation

• Horizontal displacement of the glottic plane

  During laryngoscopy, before intubation

• First-pass intubation success

  From laryngoscope insertion to first confirmed capnography

• Time to intubation

  From laryngoscope insertion to first confirmed capnography

Study Arms (3)

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.

Procedure: Cricoid Pressure (30 N)

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.

Procedure: Left Paratracheal Pressure (30 N)

Interventions

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.

Also known as: Sellick Maneuver, Cricoid Force, CP, Cricoid Compression, Cricoid Pressure

Cricoid Pressure (30 N)

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.

Also known as: LPP, Left Paratracheal Pressure

Left Paratracheal Pressure (30 N)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Clinique Saint-Luc

Bouge, Namur, Belgium

Location

MeSH Terms

Interventions

N 30

Central Study Contacts

Benjamin Javillier, M.D.

CONTACT

081209155; javillier.benjamin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)