Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia

NCT07778303 | Not Yet Recruiting

• 1 other identifier: PARANIRS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Oxygenation

Keywords

Left Paratracheal Pressure; Cricoid Pressure; Near-Infrared Spectroscopy; NIRS; Regional Cerebral Oxygen Saturation; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  During the two 45-second cervical pressure interventions

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

  During baseline and each 45-second cervical pressure intervention

• Change in Mean Arterial Pressure

  During baseline and each 60-second cervical pressure intervention

• Change in Heart Rate

  During baseline and each 45-second cervical pressure intervention

Study Arms (2)

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.

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.

Procedure: Left Paratracheal Pressure; Procedure: Cricoid Pressure

Interventions

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.

CP then LPP; LPP then CP

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.

CP then LPP; LPP then CP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Saint-Luc: lead

Study Sites (1)

Clinique Saint-Luc Bouge

Bouge, Namur, 5004, Belgium

Location

Study Officials

• Benjamin Javillier, MD

  Clinique Saint-Luc Bouge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Javillier, MD

CONTACT

+32 81 20 91 55; javillier.benjamin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

BE (1)