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NCT Number: NCT07778303

Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint-Luc Bouge

Bouge, Namur, 5004, Belgium

Location contact

Benjamin Javillier, MD

CONTACT

[email protected]

+32 81 20 91 55

Benjamin Javillier, MD

PRINCIPAL_INVESTIGATOR

Eric Deflandre, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Left Paratracheal Pressure

Procedure

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 Pressure

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Change in Right Regional Cerebral Oxygen Saturation

    Time frame: During each 45-second cervical pressure intervention, compared with the preceding baseline period

    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.

  2. Difference in Change in Left Regional Cerebral Oxygen Saturation Between LPP and Cricoid Pressure

    Time frame: During the two 45-second cervical pressure interventions

    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.

  3. Difference in Regional Cerebral Oxygen Saturation Between the Left and Right Hemispheres

    Time frame: During baseline and each 45-second cervical pressure intervention

    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.

  4. Change in Mean Arterial Pressure

    Time frame: During baseline and each 60-second cervical pressure intervention

    Change in mean arterial pressure (MAP), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.

  5. Change in Heart Rate

    Time frame: During baseline and each 45-second cervical pressure intervention

    Change in heart rate, measured in beats per minute, during left paratracheal pressure and cricoid pressure compared with baseline.

  6. Change in Peripheral Oxygen Saturation

    Time frame: During baseline and each 45-second cervical pressure intervention

    Change in peripheral oxygen saturation (SpO2), expressed as a percentage, during left paratracheal pressure and cricoid pressure compared with baseline.

  7. Change in End-Tidal Carbon Dioxide

    Time frame: During baseline and each 45-second cervical pressure intervention

    Change in end-tidal carbon dioxide (EtCO2), measured in mmHg, during left paratracheal pressure and cricoid pressure compared with baseline.

  8. Participants Requiring Vasopressor Administration

    Time frame: From baseline measurement through completion of the second cervical pressure intervention, approximately 3 minutes

    Number and proportion of participants requiring vasopressor administration during the experimental study period.

  9. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Javillier, MD

CONTACT

[email protected]

+32 81 20 91 55

Sponsors and collaborators

Lead sponsor

Clinique Saint-Luc

Network

Registry information

Official study 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

Acronym: PARANIRS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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