NCT03758937

Brief Summary

The purpose of this study is to compare volume controlled-ventilation (VCV) and pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 27, 2018

Last Update Submit

November 28, 2018

Conditions

Bariatric Surgery

Keywords

bariatric surgeryvolume-controlled ventilationpressure-controlled ventilation

Outcome Measures

Primary Outcomes (3)

  • Partial oxygen pressure

    Assessed 5 minutes after induction by using arterial blood gas analysis.

    5 minutes after induction

  • Partial oxygen pressure

    Assessed 30 minutes after pneumoperitoneum by using arterial blood gas

    30 minutes after pneumoperitoneum

  • Partial oxygen pressure

    Assessed through surgery completion, an average of 90 minutes by using arterial blood gas

    through surgery completion, an average of 90 minutes

Secondary Outcomes (6)

  • Partial carbon dioxide pressure

    5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

  • Partial carbon dioxide pressure - end-tidal carbon dioxide pressure

    5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

  • Peak airway pressure

    5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

  • Dynamic compliance

    5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

  • Inspired oxygen pressure / Fractional oxygen ratio

    5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes

  • +1 more secondary outcomes

Study Arms (2)

volume-controlled ventilation group

ACTIVE COMPARATOR

During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.

Procedure: volume-controlled ventilation

pressure-controlled ventilation group

ACTIVE COMPARATOR

During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.

Procedure: pressure-controlled ventilation

Interventions

volume-controlled ventilationPROCEDURE
volume-controlled ventilation group
pressure-controlled ventilationPROCEDURE
pressure-controlled ventilation group

Eligibility Criteria

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

You may qualify if:

  • years or above,
  • ASA II patients
  • BMI \> 40 kg / m2
  • No serious comorbidity.

You may not qualify if:

  • Unstable patients during the operation
  • The requirement for mechanical ventilation in the postoperative period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Traning and Research Hospital

Antalya, Turkey (Türkiye)

Location

Study Officials

  • Erhan Ozyurt, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

August 1, 2017

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

TU(1)