NCT03150264

Prospective Clinical Study of PCV and PCV-VG in Patients Undergoing Bariatric Surgery

The Comparison of Pressure-controlled Ventilation and Pressure-controlled Ventilation Volume-guaranteed on Respiratory Dynamics and Clinical Outcome in Patients Undergoing Bariatric Surgery: Prospective Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study compares the two mechanical ventilation strategies in obese patients undergoing bariatric surgery: pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG). This is a randomized controlled trial with a sample size of 100 patients whose body mass index(BMI) is over 30kg/m².

Detailed description

With the development of economy and changing of life style, obesity is becoming a common phenomenon. More and more obese patients are undergoing bariatric surgery every year. Obesity results in a series of physiological changes particularly the respiratory system. The decrease of lung compliance and the limited total lung capacity, vital capacity, functional residual capacity are all contributed to intraoperative hypoxemia and postoperative lung complications. Presently study mainly discuss lung protective ventilation strategies from four aspects: tidal volume,ventilation modes,positive end-expiratory pressures and lung recruitment maneuvers. This prospective study will compare two ventilation modes in obese patients undergoing bariatric surgery:pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG). The total of 100 patients will be divided into two groups randomly. The patients will be ventilated with PCV or PCV-VG modes plus positive end expiratory pressure (PEEP) of 5cmH2O throughout the whole operation. The respiratory and hemodynamic parameters in six time points will be recorded, and the postoperative chest computerized tomography (CT) will be checked to identify the postoperative lung complications.

Conditions

• Bariatric Surgery
• Mechanical Ventilation

Interventions

Type	Name	Description
DEVICE	PCV-VG, PEEP5cmH₂O	This is an innovative ventilation mode developed in recent years. The preset tidal volume help the machine modify inspiratory pressures and compensate the decrease of lung compliance.
DEVICE	PCV, PEEP5cmH₂O	This is a traditional ventilation mode used in obese patients in the past.

Timeline

• Start date: 2017-01-16
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-05-12
• Last updated: 2019-08-20

Locations

1 site across 1 country: China