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

NCT06547411 | Recruiting

• 1 other identifier: MER-068
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilation; Bariatric Surgery; Intracranial Pressure; Carbon Dioxide

Outcome Measures

Primary Outcomes (8)

• 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.

  1 year

• 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.

  1 year

• mean airway pressure (PAWM)

  Mean airway pressure throughout the ventilation cycle

  1 year

• peak airway pressure (PAP)

  Maximum pressure in the airway throughout inspiration

  1 year

• esophageal pressure (PES)

  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

  1 year

• tidal volume (TV)

  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

  1 year

• mean arterial pressure (MAP)

  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.

  1 year

• heart rate (HR)

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

  1 year

Study Arms (3)

PC Ventilation mode group

EXPERIMENTAL

Group I patients received mechanical ventilation using the PC mode. The anesthetic machine (MAQUET Flow-I, Italy) parameters were set as follows: The inspiratory pressure (Pins) was adjusted to maintain an end-tidal carbon dioxide concentration (ETCO2) of 4.0-5.0 kPa. Pure oxygen and air were utilized at 0.3 L/min each, with an oxygen content of 41%.

Device: PC Ventilation mode

VC Ventilation mode group

EXPERIMENTAL

Group II patients received mechanical ventilation in VC mode. The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height \[cm\] - 152.4); IBW for females: 45.5 + 0.91 × (height \[cm\] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41%

Device: VC Ventilation mode

PRVC Ventilation mode group

EXPERIMENTAL

Group III patients received mechanical ventilation using the PRVC mode.The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height \[cm\] - 152.4); IBW for females: 45.5 + 0.91 × (height \[cm\] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41%

Device: PRVC Ventilation mode

Interventions

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).

PC Ventilation mode group

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).

VC Ventilation mode group

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).

PRVC Ventilation mode group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yu-Long Jia: lead
• Inner Mongolia Baogang Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Long Jia

CONTACT

14747606821; jiayulong97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: March 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-08

Locations

CN (1)