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

Last updated: August 18, 2019
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Treatment

N/A

Clinical Study ID

NCT03150264
clinical review (2016) (397)
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI≥30kg/m²

  • ASA classification II-III

  • Bariatric surgery

Exclusion

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

Total Participants: 100
Study Start date:
January 16, 2017
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Fudan University Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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