PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)

Not Applicable

Not yet recruiting

• Conditions: Airway Management

• Registration Number: NCT07004998
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Study First Posted: 2025-06-04
• Status Verified: 2025-08
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Glottic Opening (POGO) score	During laryngoscopy, before tracheal intubation	POGO will be scored from video recordings of each condition (no pressure, cricoid, paratracheal) by blinded assessors (0-100%).

Secondary Outcome Measures

Name	Time	Method
Glottic surface area	During laryngoscopy, before intubation	Glottic surface area will be quantified from videolaryngoscopic images under each condition (no pressure, cricoid, paratracheal) using standardized image analysis by blinded reviewers.
Vertical Displacement of the Glottic Plane	During laryngoscopy, before intubation	The vertical shift of the glottic plane relative to baseline will be measured on recorded videolaryngoscopic images under each condition, assessed by blinded reviewers.
Horizontal displacement of the glottic plane	During laryngoscopy, before intubation	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.
First-pass intubation success	From laryngoscope insertion to first confirmed capnography	Successful tracheal intubation at the first attempt with the maneuver chosen by the operator.
Time to intubation	From laryngoscope insertion to first confirmed capnography	Duration in seconds until successful tracheal intubation.
Intubation Difficulty Scale (IDS)	During intubation	Composite score including attempts, operators, optimization maneuvers, and force required.
First-attempt success without desaturation < 90%	From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes.	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.
Hypoxemia	From induction until confirmed intubation	Oxygen saturation \<92% recorded by pulse oximetry.
Hemodynamic events	From induction until confirmed intubation	Systolic blood pressure drop \>20% from baseline or heart rate \<50/min.
Airway trauma	Immediately after intubation	Blood on blade/stylet or visible lip/mucosal injury.
Postoperative sore throat	30-60 minutes in PACU	Patient-reported throat pain on numeric scale (0-10).

Trial Locations

Locations (1)

Clinique Saint-Luc; 🇧🇪 Bouge, Namur, Belgium