PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)

NCT ID: NCT07004998

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-31

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.

Detailed Description

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.

Conditions

Airway Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No Pressure (Baseline)

Videolaryngoscopy performed without any external laryngeal pressure. This serves as the baseline condition for each patient.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cricoid Pressure (30 N)

Videolaryngoscopy performed while applying standardized cricoid pressure (30 N) by a trained operator. A video image is captured during this maneuver.

Group Type: ACTIVE_COMPARATOR

Cricoid Pressure (30 N)

Intervention Type: 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.

Left Paratracheal Pressure (30 N)

Videolaryngoscopy performed while applying standardized left paratracheal pressure (30 N) by the same operator. A video image is captured during this maneuver.

Group Type: EXPERIMENTAL

Left Paratracheal Pressure (30 N)

Intervention Type: 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.

Interventions

Cricoid Pressure (30 N)

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.

Intervention Type: PROCEDURE

Left Paratracheal Pressure (30 N)

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.

Intervention Type: PROCEDURE

Other Intervention Names

Sellick Maneuver; Cricoid Force; CP; Cricoid Compression; Cricoid Pressure; LPP; Left Paratracheal Pressure

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Javillier, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinique Saint-Luc

Bouge, Namur, Belgium

Countries

Belgium

Central Contacts

Benjamin Javillier, M.D.

Role: CONTACT

javillier.benjamin@hotmail.com

081209155 ext. +32

Facility Contacts

Benjamin Javillier, M.D.

Role: primary

javillier.benjamin@hotmail.com

081209155 ext. +32

Other Identifiers

PARAGLIDE

Identifier Type: -

Identifier Source: org_study_id