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NCT Number: NCT06547411

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

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

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Key information

Conditions

Ventilation Bariatric Surgery Carbon Dioxide Intracranial Pressure Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location status: Recruiting

Location contact

Yu-Long Jia

CONTACT

[email protected]

14747606821

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. optic nerve sheath diameter [ONSD]

    Time frame: 1 year

    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.

  2. carbon dioxide partial pressure

    Time frame: 1 year

    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.

  3. mean airway pressure (PAWM)

    Time frame: 1 year

    Mean airway pressure throughout the ventilation cycle

  4. peak airway pressure (PAP)

    Time frame: 1 year

    Maximum pressure in the airway throughout inspiration

  5. esophageal pressure (PES)

    Time frame: 1 year

    Esophageal 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

  6. tidal volume (TV)

    Time frame: 1 year

    Tidal 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

  7. mean arterial pressure (MAP)

    Time frame: 1 year

    Mean 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.

  8. heart rate (HR)

    Time frame: 1 year

    The normal adult heart rate ranges from 60 to 100 beats per minute, but infants and children have a faster heart rate than adults.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Long Jia

CONTACT

[email protected]

14747606821

Sponsors and collaborators

Lead sponsor

Yu-Long Jia

Other

Collaborators

  • Inner Mongolia Baogang Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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