NCT03150264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

April 21, 2017

Last Update Submit

August 18, 2019

Conditions

Bariatric SurgeryMechanical Ventilation

Keywords

lung protective ventilation strategiesobesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative lung complications

    five days

  • the risk factors of postoperative lung complications

    five days

Study Arms (2)

PCV-VG+PEEP5cmH₂O

EXPERIMENTAL

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

Device: PCV-VG, PEEP5cmH₂O

PCV+PEEP5cmH₂O

ACTIVE COMPARATOR

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

Device: PCV, PEEP5cmH₂O

Interventions

PCV-VG, PEEP5cmH₂ODEVICE

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-VG+PEEP5cmH₂O
PCV, PEEP5cmH₂ODEVICE

This is a traditional ventilation mode used in obese patients in the past.

PCV+PEEP5cmH₂O

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI≥30kg/m²
  • ASA classification II-III
  • Bariatric surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (2)

  • 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: 25232415RESULT

  • 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: 22976857RESULT

MeSH Terms

Conditions

Obesity

Interventions

Hematocrit

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesHemorheologyBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Weimin Liang, doctor

    Huashan Hospital

    STUDY DIRECTOR

Central Study Contacts

Pan Wu, bachelor

CONTACT

131620870781169796409@qq.com

Qiong Yu, doctor

CONTACT

13472755168yu.qiong816@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 12, 2017

Study Start

January 16, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

IPD is available only when we finish or publish the study. Please contact me via e-mail of this account.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The information is available only when we finish or publish the study. Please contact me via e-mail of this account.
Access Criteria
Open for the clinical researchers

Available IPD Datasets

Study Protocol Access

Locations

CN(1)