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

Not Applicable

• Conditions: Bariatric Surgery; Mechanical Ventilation
• Interventions: Device: PCV-VG, PEEP5cmH₂O; Device: PCV, PEEP5cmH₂O

• Registration Number: NCT03150264
• Lead Sponsor: Huashan Hospital

Brief 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.

Study Timeline

• Study Start: 2017-01-16
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI≥30kg/m²
• ASA classification II-III
• Bariatric surgery

Exclusion Criteria

• Patients combined restrictive or obstructive lung diseases,pneumonia, bullae of lung ; patients after pneumonectomy
• Patients combined with other severe internal medicine diseases
• duration of pregnancy or suckling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCV-VG+PEEP5cmH₂O	PCV-VG, PEEP5cmH₂O	Patients in this group are ventilated with pressure-controlled ventilation volume-guaranteed mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.
PCV+PEEP5cmH₂O	PCV, PEEP5cmH₂O	Patients in this group are ventilated with pressure-controlled ventilation mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.

Primary Outcome Measures

Name	Time	Method
Dynamic lung compliance measure	three hours	Dynamic lung compliance can be calculated based on tidal volume,peak inspiratory pressure and PEEP. 10minutes after induction,10minutes after pneumoperitoneum,60minutes after pneumoperitoneum and 10minutes after pneumoperitoneum release will be recorded.

Secondary Outcome Measures

Name	Time	Method
Postoperative lung complications	five days	Lung complications mainly contains pneumonia,atelectasis,pleural fluid. The investigator compare the preoperative chest CT with the postoperative chest CT and follow-up participants until participants leave hospital.
the risk factors of postoperative lung complications	five days	risk factors may include age, gender, BMI, ventilation duration, etc

Trial Locations

Locations (1)

Fudan University Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China