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NCT Number: NCT06805747

A Comparative Study of Ventilation Strategies in Different Surgical Positions on Intracranial Pressure and Cerebral Blood Flow During Laparoscopic Surgery

The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) on esophageal pressure, airway pressure, tidal volume, intracranial pressure, and cerebral blood flow.

The study aims to address the following primary questions:Does laparoscopic surgery in the Trendelenburg or Reverse Trendelenburg position increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? Do variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV) increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? The investigators will compare variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to determine which ventilation mode results in the least physiological disturbance for patients.

Participant Procedures:

Participants will: Be positioned according to the surgical requirements.Be randomly assigned to mechanical ventilation with either variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).

Undergo assessments at the following time points: immediately after endotracheal intubation, immediately after pneumoperitoneum, immediately after position change (Trendelenburg or Reverse Trendelenburg), 30 minutes after position change, and 1 hour after position change.

Have their esophageal pressure, airway pressure, intracranial pressure, tidal volume, and internal jugular vein blood flow recorded at each assessment time point.

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Key information

Conditions

Laparoscopic Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location contact

Xiangyu Wang XY Wang, Undergraduate

CONTACT

[email protected]

+86 0472 5992830

Xiaoyu Zhang

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: Unrestricted
  • American Society of Anesthesiologists (ASA) Physical Status: Class I-III
  • Surgical Position: Requires the use of either the Trendelenburg position or the Reverse Trendelenburg position during the procedure.
  • Ventilation: Planned mechanical ventilation is required during the procedure, with suitability for one of the following modes: pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).

Exclusion criteria

  • Significant Cardiopulmonary Disease:
  • Intracranial Disease
  • Severe Coagulopathy or Current Anticoagulant Therapy
  • Presence of Psychiatric Illness, Cognitive Impairment, or other condition that precludes the ability to understand or comply with the study.

Treatment and study plan

variable tidal volume ventilation (V-VCV)

Other

Variable tidal volume ventilation (V-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.

pressure-regulated volume-controlled ventilation (PRVC)

Other

Pressure-regulated volume-controlled ventilation (PRVC) ：Initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), peak inspiratory pressure is capped at 30 cmH2O, maximum tidal volume (Vt_max), and minimum tidal volume (Vt_min) is set at 10-20% of basal tidal volume (Vt_base). Respiratory Rate (RR) 12, Inspiratory Breathing Ratio (IBR) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.

conventional volume-controlled ventilation (C-VCV)

Other

Conventional volume-controlled ventilation (C-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, FiO2 98%.

pressure-controlled ventilation (PCV)

Other

Pressure-controlled ventilation (PCV)：Set inspiratory pressure level, usually 20 cmH2O initial value, Respiratory Rate 12, Inspiratory to Expiratory Ratio 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, Inhaled Oxygen Concentration (FiO2) 98%.

Trendelenburg position

Other

Trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Reverse Trendelenburg position

Other

Reverse Trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.

Primary outcomes

  1. esophageal pressure

    Time frame: immediately after tracheal intubation

  2. airway pressure

    Time frame: immediately after tracheal intubation

  3. intracranial pressure

    Time frame: immediately after pneumoperitoneum

  4. tidal volume

    Time frame: immediately after tracheal intubation

  5. carotid blood flow

    Time frame: half an hour after change of position

Study contacts

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

Xiaguang XG Duan, Master's degree

CONTACT

[email protected]

+86 13314720012

Sponsors and collaborators

Lead sponsor

Inner Mongolia Baogang Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

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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