NCT06805747

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

Not yet recruiting NA Last updated 3 February 2025

What this trial tests

NA trial testing Variable tidal volume ventilation (V-VCV) in Laparoscopic Surgery in 240 participants. Not yet recruiting.

Timeline

1 February 2025

Primary endpoint
1 May 2025

10 May 2025

Quick facts

Lead sponsor	Inner Mongolia Baogang Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	240
Start date	1 February 2025
Primary completion	1 May 2025
Estimated completion	10 May 2025
Sites	1 location across China

Drugs / interventions tested

• Variable tidal volume ventilation (V-VCV)
• Pressure-regulated volume-controlled ventilation (PRVC)
• Conventional volume-controlled ventilation (C-VCV)
• Pressure-controlled ventilation (PCV)
• Trendelenburg position
• Reverse Trendelenburg position

Conditions studied

• Laparoscopic Surgery — all drugs for Laparoscopic Surgery →

Sponsor

Inner Mongolia Baogang Hospital

Who can join

Eligibility, any sex, with Laparoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.