Airway ManagementPARAGLIDENCT07004998
PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)
A study testing Cricoid Pressure (30 N) and Left Paratracheal Pressure (30 N) in people with Airway Management, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Cricoid Pressure (30 N) and Left Paratracheal Pressure (30 N)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Clinique Saint-Luc
Bouge, Namur
Benjamin Javillier, M.D., 081209155 ext. +32, javillier.benjamin@hotmail.com
About this study
Official title: Comparison of Left Paratracheal Versus Cricoid Pressure on Glottic Visualization During Videolaryngoscopy: A Randomized Crossover Study
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.
Read the 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
- Being tested
- Cricoid Pressure (30 N), Left Paratracheal Pressure (30 N)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid Pressure (30 N)Procedure or surgery
Also called Sellick Maneuver, Cricoid Force, CP, Cricoid Compression
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)Procedure or surgery
Also called LPP, Left Paratracheal Pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Left Paratracheal Pressure (30 N) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: During laryngoscopy, before tracheal intubation
Secondary outcomes (11)
Glottic surface area
Glottic surface area will be quantified from videolaryngoscopic images under each condition (no pressure, cricoid, paratracheal) using standardized image analysis by blinded reviewers.
Measured: During laryngoscopy, before intubation
Vertical Displacement of the Glottic Plane
The vertical shift of the glottic plane relative to baseline will be measured on recorded videolaryngoscopic images under each condition, assessed by blinded reviewers.
Measured: During laryngoscopy, before intubation
Horizontal displacement of the glottic plane
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.
Measured: During laryngoscopy, before intubation
First-pass intubation success
Successful tracheal intubation at the first attempt with the maneuver chosen by the operator.
Measured: From laryngoscope insertion to first confirmed capnography
Time to intubation
Duration in seconds until successful tracheal intubation.
Measured: From laryngoscope insertion to first confirmed capnography
Intubation Difficulty Scale (IDS)
Composite score including attempts, operators, optimization maneuvers, and force required.
Measured: During intubation
First-attempt success without desaturation < 90%
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.
Measured: From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes.
Hypoxemia
Oxygen saturation <92% recorded by pulse oximetry.
Measured: From induction until confirmed intubation
Hemodynamic events
Systolic blood pressure drop >20% from baseline or heart rate <50/min.
Measured: From induction until confirmed intubation
Airway trauma
Blood on blade/stylet or visible lip/mucosal injury.
Measured: Immediately after intubation
Postoperative sore throat
Patient-reported throat pain on numeric scale (0-10).
Measured: 30-60 minutes in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, MD, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004998
- Sponsor's protocol ID
- PARAGLIDE
- Acronym
- PARAGLIDE
- Status last verified
- Aug 2025
- First submitted
- 26 May 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What: de-identified outcome data (clinical and imaging) and analysis code; selected de-identified video frames. When: after publication. How: upon reasonable request to the sponsor/PI with data-use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Left Paratracheal Versus Cricoid Pressure on Glottic Visualization During Videolaryngoscopy: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07004998
- Acronym / sponsor ID
- PARAGLIDE / PARAGLIDE
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: 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. |
| Left Paratracheal Pressure (30 N) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cricoid Pressure (30 N)Also: Sellick Maneuver, Cricoid Force, CP, Cricoid CompressionManual 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. | Procedure or surgery | Cricoid Pressure (30 N) |
| Left Paratracheal Pressure (30 N)Also: LPP, Left Paratracheal PressureManual 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. | Procedure or surgery | Left Paratracheal Pressure (30 N) |
Primary outcome
Percentage of Glottic Opening (POGO) score
Time frame: During laryngoscopy, before tracheal intubation
POGO will be scored from video recordings of each condition (no pressure, cricoid, paratracheal) by blinded assessors (0-100%).
11 secondary outcomes
Glottic surface area
Time frame: During laryngoscopy, before intubation
Vertical Displacement of the Glottic Plane
Time frame: During laryngoscopy, before intubation
Horizontal displacement of the glottic plane
Time frame: During laryngoscopy, before intubation
First-pass intubation success
Time frame: From laryngoscope insertion to first confirmed capnography
Time to intubation
Time frame: From laryngoscope insertion to first confirmed capnography
Intubation Difficulty Scale (IDS)
Time frame: During intubation
First-attempt success without desaturation < 90%
Time frame: From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes.
Hypoxemia
Time frame: From induction until confirmed intubation
Hemodynamic events
Time frame: From induction until confirmed intubation
Airway trauma
Time frame: Immediately after intubation
Postoperative sore throat
Time frame: 30-60 minutes in PACU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. What: de-identified outcome data (clinical and imaging) and analysis code; selected de-identified video frames. When: after publication. How: upon reasonable request to the sponsor/PI with data-use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricoid Pressure (30 N) and Left Paratracheal Pressure (30 N) in people with Airway Management, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, M.D. (081209155 ext. +32, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Glottic Opening (POGO) score (time frame: During laryngoscopy, before tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.