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

Fudan University

Status: Unknown

Conditions: Bariatric Surgery; Mechanical Ventilation

Treatments: Device: PCV, PEEP5cmH₂O; Device: PCV-VG, PEEP5cmH₂O

Study type: Interventional

Funder types: Other

Identifiers

NCT03150264

clinical review (2016) (397)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

PCV-VG+PEEP5cmH₂O

Experimental group

Description:

Patients in this group are ventilated with pressure-controlled ventilation volume-guaranteed mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.

Treatment:

Device: PCV-VG, PEEP5cmH₂O

PCV+PEEP5cmH₂O

Active Comparator group

Description:

Patients in this group are ventilated with pressure-controlled ventilation mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.

Treatment:

Device: PCV, PEEP5cmH₂O