Cerebral OxygenationPARANIRSNCT07778303
Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia
A study testing Left Paratracheal Pressure and Cricoid Pressure in people with Cerebral Oxygenation, run by Clinique Saint-Luc at 1 site in Belgium.
Trial summary
Left paratracheal pressure (LPP) has been proposed as an alternative to cricoid pressure to reduce the risk of regurgitation during induction of general anesthesia. Previous studies suggest that LPP can effectively compress the esophagus without significantly reducing left carotid blood flow. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation
- What is being tested?
- Left Paratracheal Pressure and Cricoid Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2026to Jun 2027
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled for elective surgery requiring general anesthesia with orotracheal intubation
- American Society of Anesthesiologists (ASA) physical status I to III
- Ability to understand the study information
- Written informed consent obtained before study procedures
Who cannot join
- Refusal to participate
- Known or suspected pregnancy
- Emergency surgery
- Inability to provide informed consent
- History of stroke or transient ischemic attack within the previous 6 months
- Known severe carotid artery stenosis (>70%) or previous carotid surgery
Show all 10Show fewer
- Known intracranial hypertension
- Cervical malformation or previous cervical surgery preventing correct application of left paratracheal pressure or cricoid pressure
- Technical inability to correctly position the NIRS sensors
- Any condition considered by the investigator to be incompatible with study participation
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
Bouge, Namur, 5004
Benjamin Javillier, MD, +32 81 20 91 55, javillier.benjamin@hotmail.com
Benjamin Javillier, MD
About this study
Official title: Prospective Randomized Crossover Study of the Effect of Left Paratracheal Pressure on Regional Cerebral Oxygenation Measured by Near-Infrared Spectroscopy During General Anesthesia Induction
Left paratracheal pressure (LPP) has been proposed as an alternative to cricoid pressure to reduce the risk of regurgitation during induction of general anesthesia. Previous studies suggest that LPP can effectively compress the esophagus without significantly reducing left carotid blood flow. However, its effect on cerebral oxygenation has not yet been evaluated.
The aim of this prospective randomized crossover study is to assess whether application of LPP affects regional cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS) during general anesthesia.
Read more
Seventy adult patients undergoing elective surgery under general anesthesia with tracheal intubation will be included. After induction of anesthesia and stabilization, cerebral oxygen saturation will be continuously measured under three conditions: no cervical pressure, left paratracheal pressure at 30 N, and cricoid pressure at 30 N. The order of the two pressure maneuvers will be randomized.
The primary objective is to determine the change in left regional cerebral oxygen saturation during LPP compared with baseline without cervical pressure.
Read the detailed description
Pulmonary aspiration of gastric contents remains a potentially serious complication of general anesthesia. Cricoid pressure has traditionally been used during induction of anesthesia to reduce the risk of regurgitation, although its effectiveness and its potential effects on airway management remain debated.
Left paratracheal pressure (LPP) has been proposed as an alternative technique based on the frequent left-sided position of the cervical esophagus. Anatomical and clinical studies have suggested that LPP may provide effective esophageal compression while preserving airway management conditions. Previous work from the investigators also showed that application of LPP at 30 N did not significantly decrease left carotid blood flow. However, carotid blood flow is an indirect marker of cerebral perfusion, and the effect of LPP on cerebral oxygenation remains unknown.
PARANIRS is a prospective, single-center, randomized, controlled crossover study designed to evaluate the effect of LPP on regional cerebral oxygen saturation during general anesthesia. Each participant will serve as their own control.
After induction of general anesthesia, neuromuscular blockade, tracheal intubation, and hemodynamic stabilization, bilateral regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy. Measurements will be obtained during a baseline period without cervical pressure and during application of two cervical pressure maneuvers: left paratracheal pressure at 30 N and cricoid pressure at 30 N.
The order of the two cervical pressure maneuvers will be randomized. Each maneuver will be applied for 60 seconds using a calibrated force-measuring device to ensure a constant force of 30 N, with a 60-second washout period between interventions.
Hemodynamic and respiratory variables, including mean arterial pressure, heart rate, peripheral oxygen saturation, and end-tidal carbon dioxide, will also be continuously recorded. The study is intended to determine whether LPP produces a clinically relevant change in regional cerebral oxygenation and to compare its physiological effects with those of conventional cricoid pressure.
- Conditions
- Cerebral Oxygenation
- Being tested
- Left Paratracheal Pressure, Cricoid Pressure
- Keywords
- Left Paratracheal Pressure, Cricoid Pressure, Near-Infrared Spectroscopy, NIRS, Regional Cerebral Oxygen Saturation, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Paratracheal PressureProcedure or surgery
A standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.
Cricoid PressureProcedure or surgery
A standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| LPP then CP | Experimental | Participants undergo baseline measurements without cervical pressure, followed by left paratracheal pressure (LPP) at 30 N for 45 seconds, a 60-second washout period, and then cricoid pressure (CP) at 30 N for 45 seconds. Receives: Procedure: Left Paratracheal Pressure; Procedure: Cricoid Pressure |
| CP then LPP | Experimental | Participants undergo baseline measurements without cervical pressure, followed by cricoid pressure (CP) at 30 N for 45 seconds, a 60-second washout period, and then left paratracheal pressure (LPP) at 30 N for 45 seconds. Receives: Procedure: Left Paratracheal Pressure; Procedure: Cricoid Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Change in Left Regional Cerebral Oxygen Saturation During Left Paratracheal Pressure
Maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of left paratracheal pressure at 30 N compared with the baseline value obtained without cervical pressure.
Measured: During the 45-second application of left paratracheal pressure, compared with the preceding baseline period
Secondary outcomes (9)
Maximum Change in Right Regional Cerebral Oxygen Saturation
Maximum absolute change in right regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of each cervical pressure maneuver compared with the baseline value obtained without cervical pressure.
Measured: During each 45-second cervical pressure intervention, compared with the preceding baseline period
Difference in Change in Left Regional Cerebral Oxygen Saturation Between LPP and Cricoid Pressure
Within-participant difference in the maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, between left paratracheal pressure at 30 N and cricoid pressure at 30 N.
Measured: During the two 45-second cervical pressure interventions
Difference in Regional Cerebral Oxygen Saturation Between the Left and Right Hemispheres
Difference in regional cerebral oxygen saturation (rSO2), expressed in percentage points, between the left and right cerebral hemispheres during baseline, left paratracheal pressure, and cricoid pressure.
Measured: During baseline and each 45-second cervical pressure intervention
Change in Mean Arterial Pressure
Change in mean arterial pressure (MAP), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.
Measured: During baseline and each 60-second cervical pressure intervention
Change in Heart Rate
Change in heart rate, measured in beats per minute, during left paratracheal pressure and cricoid pressure compared with baseline.
Measured: During baseline and each 45-second cervical pressure intervention
Change in Peripheral Oxygen Saturation
Change in peripheral oxygen saturation (SpO2), expressed as a percentage, during left paratracheal pressure and cricoid pressure compared with baseline.
Measured: During baseline and each 45-second cervical pressure intervention
Change in End-Tidal Carbon Dioxide
Change in end-tidal carbon dioxide (EtCO2), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.
Measured: During baseline and each 45-second cervical pressure intervention
Participants Requiring Vasopressor Administration
Number and proportion of participants requiring vasopressor administration during the experimental study period.
Measured: From baseline measurement through completion of the second cervical pressure intervention, approximately 3 minutes
Participants With Adverse Events Related to Cervical Pressure Maneuvers
Number and proportion of participants experiencing an adverse event considered related to left paratracheal pressure or cricoid pressure during the experimental study period. Events leading to premature interruption of either maneuver will also be recorded.
Measured: From application of the first cervical pressure maneuver through completion of the second maneuver, approximately 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral OxygenationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will undergo both cervical pressure interventions in a randomized crossover sequence. All participants will first undergo a baseline period without cervical pressure, followed by left paratracheal pressure (LPP) and cricoid pressure (CP) in randomized order, with a 60-second washout period between interventions.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Luc
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Benjamin Javillier, MD, Principal investigator, Clinique Saint-Luc Bouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778303
- Sponsor's protocol ID
- PARANIRS
- Acronym
- PARANIRS
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical, regulatory, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Crossover Study of the Effect of Left Paratracheal Pressure on Regional Cerebral Oxygenation Measured by Near-Infrared Spectroscopy During General Anesthesia Induction
- ClinicalTrials.gov ID
- NCT07778303
- Acronym / sponsor ID
- PARANIRS / PARANIRS
- Conditions
- Cerebral Oxygenation
- Keywords
- Left Paratracheal Pressure, Cricoid Pressure, Near-Infrared Spectroscopy, NIRS, Regional Cerebral Oxygen Saturation, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Clinique Saint-LucResearch network
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Aug 2026 (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.
Left paratracheal pressure (LPP) has been proposed as an alternative to cricoid pressure to reduce the risk of regurgitation during induction of general anesthesia. Previous studies suggest that LPP can effectively compress the esophagus without significantly reducing left carotid blood flow. However, its effect on cerebral oxygenation has not yet been evaluated.
The aim of this prospective randomized crossover study is to assess whether application of LPP affects regional cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS) during general anesthesia.
Seventy adult patients undergoing elective surgery under general anesthesia with tracheal intubation will be included. After induction of anesthesia and stabilization, cerebral oxygen saturation will be continuously measured under three conditions: no cervical pressure, left paratracheal pressure at 30 N, and cricoid pressure at 30 N. The order of the two pressure maneuvers will be randomized.
The primary objective is to determine the change in left regional cerebral oxygen saturation during LPP compared with baseline without cervical pressure.
Detailed description
Pulmonary aspiration of gastric contents remains a potentially serious complication of general anesthesia. Cricoid pressure has traditionally been used during induction of anesthesia to reduce the risk of regurgitation, although its effectiveness and its potential effects on airway management remain debated.
Left paratracheal pressure (LPP) has been proposed as an alternative technique based on the frequent left-sided position of the cervical esophagus. Anatomical and clinical studies have suggested that LPP may provide effective esophageal compression while preserving airway management conditions. Previous work from the investigators also showed that application of LPP at 30 N did not significantly decrease left carotid blood flow. However, carotid blood flow is an indirect marker of cerebral perfusion, and the effect of LPP on cerebral oxygenation remains unknown.
PARANIRS is a prospective, single-center, randomized, controlled crossover study designed to evaluate the effect of LPP on regional cerebral oxygen saturation during general anesthesia. Each participant will serve as their own control.
After induction of general anesthesia, neuromuscular blockade, tracheal intubation, and hemodynamic stabilization, bilateral regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy. Measurements will be obtained during a baseline period without cervical pressure and during application of two cervical pressure maneuvers: left paratracheal pressure at 30 N and cricoid pressure at 30 N.
The order of the two cervical pressure maneuvers will be randomized. Each maneuver will be applied for 60 seconds using a calibrated force-measuring device to ensure a constant force of 30 N, with a 60-second washout period between interventions.
Hemodynamic and respiratory variables, including mean arterial pressure, heart rate, peripheral oxygen saturation, and end-tidal carbon dioxide, will also be continuously recorded. The study is intended to determine whether LPP produces a clinically relevant change in regional cerebral oxygenation and to compare its physiological effects with those of conventional cricoid pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will undergo both cervical pressure interventions in a randomized crossover sequence. All participants will first undergo a baseline period without cervical pressure, followed by left paratracheal pressure (LPP) and cricoid pressure (CP) in randomized order, with a 60-second washout period between interventions.
| Arm | Type | Receives |
|---|---|---|
| LPP then CP | Experimental | Procedure: Left Paratracheal Pressure, Procedure: Cricoid PressureParticipants undergo baseline measurements without cervical pressure, followed by left paratracheal pressure (LPP) at 30 N for 45 seconds, a 60-second washout period, and then cricoid pressure (CP) at 30 N for 45 seconds. |
| CP then LPP | Experimental | Procedure: Left Paratracheal Pressure, Procedure: Cricoid PressureParticipants undergo baseline measurements without cervical pressure, followed by cricoid pressure (CP) at 30 N for 45 seconds, a 60-second washout period, and then left paratracheal pressure (LPP) at 30 N for 45 seconds. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Scheduled for elective surgery requiring general anesthesia with orotracheal intubation
- American Society of Anesthesiologists (ASA) physical status I to III
- Ability to understand the study information
- Written informed consent obtained before study procedures
Key exclusion criteria (10 listed)
- Refusal to participate
- Known or suspected pregnancy
- Emergency surgery
- Inability to provide informed consent
- History of stroke or transient ischemic attack within the previous 6 months
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 |
|---|---|---|
| Left Paratracheal PressureA standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention. | Procedure or surgery | CP then LPP, LPP then CP |
| Cricoid PressureA standardized cricoid pressure of 30 N will be applied for 45 seconds using a calibrated force-measuring device. Regional cerebral oxygen saturation, hemodynamic variables, and respiratory variables will be continuously recorded during the intervention. | Procedure or surgery | CP then LPP, LPP then CP |
Primary outcome
Maximum Change in Left Regional Cerebral Oxygen Saturation During Left Paratracheal Pressure
Time frame: During the 45-second application of left paratracheal pressure, compared with the preceding baseline period
Maximum absolute change in left regional cerebral oxygen saturation (rSO2), expressed in percentage points, during application of left paratracheal pressure at 30 N compared with the baseline value obtained without cervical pressure.
9 secondary outcomes
Maximum Change in Right Regional Cerebral Oxygen Saturation
Time frame: During each 45-second cervical pressure intervention, compared with the preceding baseline period
Difference in Change in Left Regional Cerebral Oxygen Saturation Between LPP and Cricoid Pressure
Time frame: During the two 45-second cervical pressure interventions
Difference in Regional Cerebral Oxygen Saturation Between the Left and Right Hemispheres
Time frame: During baseline and each 45-second cervical pressure intervention
Change in Mean Arterial Pressure
Time frame: During baseline and each 60-second cervical pressure intervention
Change in Heart Rate
Time frame: During baseline and each 45-second cervical pressure intervention
Change in Peripheral Oxygen Saturation
Time frame: During baseline and each 45-second cervical pressure intervention
Change in End-Tidal Carbon Dioxide
Time frame: During baseline and each 45-second cervical pressure intervention
Participants Requiring Vasopressor Administration
Time frame: From baseline measurement through completion of the second cervical pressure intervention, approximately 3 minutes
Participants With Adverse Events Related to Cervical Pressure Maneuvers
Time frame: From application of the first cervical pressure maneuver through completion of the second maneuver, approximately 3 minutes
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical, regulatory, and institutional requirements.
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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.
Benjamin Javillier, MD principal investigator
Clinique Saint-Luc Bouge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Paratracheal Pressure and Cricoid Pressure in people with Cerebral Oxygenation, run by Clinique Saint-Luc 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 10 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 21 Aug 2026. 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, MD (+32 81 20 91 55, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Change in Left Regional Cerebral Oxygen Saturation During Left Paratracheal Pressure (time frame: During the 45-second application of left paratracheal pressure, compared with the preceding baseline period). 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 21 Aug 2026.