Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
Healthy Volunteers
ID06547411

Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study

Led by Yu-Long Jia · Updated on 2025-03-05

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yu-Long Jia

Lead Sponsor

I

Inner Mongolia Baogang Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to explore the clinical importance of different ventilation modes in patients undergoing bariatric surgery. It focuses on whether various ventilation patterns affect intracranial pressure and the partial pressure of carbon dioxide, and whether pressure-regulated volume control (PRVC) ventilation reduces these measurements. The study also investigates if intracranial pressure can be quickly assessed by monitoring the optic nerve sheath diameter (ONSD). Participants are randomly assigned to one of three groups receiving different ventilation modes during surgery: pressure control (PC), volume control (VC), or pressure-regulated volume control (PRVC). Each group uses specific settings tailored to maintain proper oxygen levels and breathing parameters, including tidal volume based on ideal body weight, positive end-expiratory pressure, and respiratory rate. The study compares respiratory mechanics, carbon dioxide levels, and optic nerve sheath diameter among the groups. During the study, researchers monitor several outcomes including ONSD, carbon dioxide partial pressure, mean and peak airway pressures, esophageal pressure, tidal volume, mean arterial pressure, and heart rate over one year. Participants undergo these assessments throughout the trial to evaluate the impact of the ventilation modes on breathing and intracranial pressure. The study involves follow-up and data collection to understand how these ventilation techniques perform in bariatric surgery patients.

CONDITIONS

Brief Title

Effects of Different Anesthesia Machine Modalities on Bariatric Surgery Patients: a Prospective Randomized Controlled Study

Who Can Participate

Age: 16Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective bariatric surgery
  • Age between 16 and 65 years
  • Continuous weight gain for more than 5 years with a BMI ≥ 35
  • ASA-PS Grade II or III
Not Eligible

You will not qualify if you...

  • Dependence on alcohol or opioids
  • Severe mental or intellectual disabilities
  • Severe ocular conditions such as ocular trauma, optic nerve tumors, or wearing ocular prostheses

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Duration of the bariatric surgery procedure

Participants receive mechanical ventilation during bariatric surgery using one of three ventilation modes: Pressure Control (PC), Volume Control (VC), or Pressure-Regulated Volume Control (PRVC).

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 1 year after surgery

Participants are monitored for outcomes including optic nerve sheath diameter, carbon dioxide partial pressure, airway pressures, and vital signs for up to 1 year after surgery.

Periodic visits for follow-up assessments over 1 year

Trial Site Locations

Total: 1 location

1

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China, 014010

Actively Recruiting

Loading map...

Research Team

Y

Yu-Long Jia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Preoperative Tirzepatide Treatment Compared to Standard Care...

Obesity and Obesity-related Medical Conditions

Actively Recruiting

1 location

Bone and Muscle Health Following Sleeve Gastrectomy in Men, ...

Bariatric Surgery

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here