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

NCT03150264 — Not applicable, Unknown, 100 participants, Huashan Hospital

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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

RegistryNCT03150264
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment100 (Estimated)
SponsorHuashan Hospital (Other)
ConditionsBariatric Surgery, Mechanical Ventilation
InterventionsPCV-VG, PEEP5cmH₂O, PCV, PEEP5cmH₂O (Device)
Datesstart 2017-01-16, primary completion 2019-12-31 (estimated), completion 2019-12-31 (estimated), first posted 2017-05-12, last updated 2019-08-20
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PCV-VG+PEEP5cmH₂OExperimentalDevice: PCV-VG, PEEP5cmH₂OPatients in this group are ventilated with pressure-controlled ventilation volume-guaranteed mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.
PCV+PEEP5cmH₂OActive comparatorDevice: PCV, PEEP5cmH₂OPatients in this group are ventilated with pressure-controlled ventilation mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.
  • PCV-VG, PEEP5cmH₂O (Device): 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 (Device): This is a traditional ventilation mode used in obese patients in the past.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Fudan University Huashan HospitalShanghai, Shanghai MunicipalityChinaRecruiting

+Publications

  • Results publication: 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. PMID 25232415
  • Results publication: 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. PMID 22976857

+Investigators

My Notes