Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06547411
Enrollment
90
Registered
2024-08-09
Start date
2024-03-01
Completion date
2025-03-30
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Carbon Dioxide, Intracranial Pressure, Ventilation

Brief summary

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

DEVICEPC 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).

DEVICEVC 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).

DEVICEPRVC 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).

Sponsors

Yu-Long Jia
Lead SponsorOTHER
Inner Mongolia Baogang Hospital
CollaboratorOTHER
The Affiliated Hospital of Inner Mongolia Medical University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
optic nerve sheath diameter [ONSD]1 yearPatients were positioned supine with their eyes softly closed, and their eyes were protected with disposable transparent patches. A 7.5 MHz linear probe (Micromaxx Ultrasound System; SonoSite Inc., Bothell, WA, USA) was gently placed on the closed upper eyelid without applying pressure to the eyeball, and sufficient ultrasound gel was applied to ensure clear imaging. The optic nerve sheath was checked and measured 3 mm beyond the globe, and three ONSD measures were performed, with the average value utilized as the final ONSD measurement, which was accurate to 0.01 mm.
carbon dioxide partial pressure1 yearArterial blood carbon dioxide partial pressure, is an important indicator of alveolar ventilation, reflecting the respiratory factors in acid-base balance. Its reference value is usually 35-45 mmHg.
mean airway pressure (PAWM)1 yearMean airway pressure throughout the ventilation cycle
peak airway pressure (PAP)1 yearMaximum pressure in the airway throughout inspiration
esophageal pressure (PES)1 yearEsophageal manometry is the recording of pressure changes in various parts of the esophagus at rest and after swallowing, and is used to indicate the motor function of the upper and lower esophageal sphincters and the body of the esophagus, and to understand esophageal motility
tidal volume (TV)1 yearTidal volume is the volume of gas inhaled or exhaled each time when breathing calmly, it is an indicator to show lung volume, mainly used for ventilation function test in pulmonary function test. Tidal volume is the basis for assessing lung function and ventilation efficiency, and is an important indicator of lung volume
mean arterial pressure (MAP)1 yearMean arterial pressure is the average push given by the heart to blood flow throughout the cardiac cycle, with systolic pressure being the peak pressure and diastolic pressure being the pressure nadir.
heart rate (HR)1 yearThe normal adult heart rate ranges from 60 to 100 beats per minute, but infants and children have a faster heart rate than adults.

Countries

China

Contacts

Primary ContactYu-Long Jia
jiayulong97@gmail.com14747606821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026