Clinical trial NCT03150264: Prospective Clinical Study of PCV and PCV-VG in Patients Undergoing Bariatric Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Mechanical Ventilation
Keywords: lung protective ventilation strategies
obesity
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic lung compliance measure
timeFrame: three hours
Secondary outcomes:
measure: Postoperative lung complications
timeFrame: five days
measure: the risk factors of postoperative lung complications
timeFrame: five days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Weimin Liang, doctor
role: STUDY_DIRECTOR
References:
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. 2014 Aug 15;7(8):2242-7. eCollection 2014.
citation: Aldenkortt M, Lysakowski C, Elia N, Brochard L, Tramer 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.