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

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150264
• Other study ID #: clinical review (2016) (397)
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Huashan Hospital
• Contact: Pan Wu, bachelor
• Phone: 13162087078
• Email: 1169796409[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Mechanical Ventilation

Intervention

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.
• PCV, PEEP5cmH2O
This is a traditional ventilation mode used in obese patients in the past.

Locations

Country	Name	City	State
China	Fudan University Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Aldenkortt M, Lysakowski C, Elia N, Brochard L, Tramèr MR. Ventilation strategies in obese patients undergoing surgery: a quantitative systematic review and meta-analysis. Br J Anaesth. 2012 Oct;109(4):493-502. doi: 10.1093/bja/aes338. Review. — View Citation

Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic lung compliance measure	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.	three hours
Secondary	Postoperative lung complications	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.	five days
Secondary	the risk factors of postoperative lung complications	risk factors may include age, gender, BMI, ventilation duration, etc	five days