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

NCT ID: NCT06547411

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PC Ventilation mode group

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%.

Group Type: EXPERIMENTAL

PC Ventilation mode

Intervention Type: 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 group

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%

Group Type: EXPERIMENTAL

VC Ventilation mode

Intervention Type: 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 group

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%

Group Type: EXPERIMENTAL

PRVC Ventilation mode

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inner Mongolia Baogang Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role: collaborator

Yu-Long Jia

OTHER

Sponsor Role: lead

Responsible Party

Yu-Long Jia

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu-Long Jia

Role: CONTACT

jiayulong97@gmail.com

14747606821

Facility Contacts

Yu-Long Jia

Role: primary

jiayulong97@gmail.com

14747606821

Other Identifiers

MER-068

Identifier Type: -

Identifier Source: org_study_id