Effects of Different Anesthesia Machine Modalities on Bariatric Surgery Patients: a Prospective Randomized Controlled Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PC Ventilation mode, VC Ventilation mode, PRVC Ventilation mode.
- Who it may be relevant to
- Registry conditions: Ventilation, Bariatric Surgery, Intracranial Pressure, Carbon Dioxide. Basic parameters: 16 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study
Overview
The goal of this clinical trial is to explore the clinical significance and value of the PRVC ventilation mode in Bariatric Surgery Patients. The main questions it aims to answer are： * Do different ventilation patterns affect intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients? * Does PRVC mode reduce intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients? * Whether intracranial pressure can be quickly measured by monitoring a patient's optic nerve sheath diameter (ONSD)？ Researchers randomized bariatric surgery patients into PC, VC, and PRVC groups for comparison, looking at breathing mechanics, PaCO2, and ICP. Participants will: * take PC mode ventilation, VC mode ventilation, and PRVC mode ventilation * monitor Respiratory mechanics, PaCO2, and ONSD
Interventions
- Device PC Ventilation mode
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group I received pressure control ventilation (PC). - Device VC Ventilation mode
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group II received volume control ventilation (VC). - Device PRVC Ventilation mode
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group III received pressure-regulated volume control ventilation (PRVC).
Primary outcome measures
- optic nerve sheath diameter [ONSD] [Time frame: 1 year]
- carbon dioxide partial pressure [Time frame: 1 year]
- mean airway pressure (PAWM) [Time frame: 1 year]
- peak airway pressure (PAP) [Time frame: 1 year]
- esophageal pressure (PES) [Time frame: 1 year]
- tidal volume (TV) [Time frame: 1 year]
- mean arterial pressure (MAP) [Time frame: 1 year]
- heart rate (HR) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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 (American Society of Anesthesiologists Physical Status) categorization of Grade II or III.
Exclusion criteria
- Patients who were dependent on alcohol or opioids.
- Patients with severe mental or intellectual disabilities.
- Patients with severe ocular conditions, such as ocular trauma, optic nerve tumors, or those wearing ocular prostheses.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Inner Mongolia Baogang Hospital — Baotou
Identifiers
NCT: NCT06547411 · MER-068