Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
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