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

ConditionsVentilationBariatric SurgeryIntracranial PressureCarbon Dioxide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorYu-Long Jia

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PC Ventilation mode

    Device

    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).

  • VC Ventilation mode

    Device

    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).

  • PRVC Ventilation mode

    Device

    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).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PC Ventilation mode groupExperimental treatment 1 intervention
Group B: VC Ventilation mode groupExperimental treatment 1 intervention
Group C: PRVC Ventilation mode groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

optic nerve sheath diameter [ONSD]

Patients 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.

Time frame
1 year
2

carbon dioxide partial pressure

Arterial 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.

Time frame
1 year
3

mean airway pressure (PAWM)

Mean airway pressure throughout the ventilation cycle

Time frame
1 year
4

peak airway pressure (PAP)

Maximum pressure in the airway throughout inspiration

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yu-Long Jia

Lead sponsor

Inner Mongolia University of Science and Technology

Sponsor institution

Inner Mongolia Baogang Hospital

Collaborator

The Affiliated Hospital of Inner Mongolia Medical University

Collaborator

Source ClinicalTrials.gov
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