Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery

January 18, 2023 updated by: Reyhan Nil Kırsan, Istanbul University

Comparison of Pressure and Volume Controlled Ventilation in Terms of Mechanical Power in Upper Abdominal Surgery

Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation

Study Overview

Detailed Description

The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Istanbul University, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA1-2 , >18 years old patients having upper abdominal surgery

Exclusion Criteria:

  • chronic obstructive lung disease, interstitial lung disease
  • chronic renal failure
  • Child-Pugh > 6 liver disease
  • Patients who don't give consent
  • NYHA > 2 heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
group 1 starts with volume controlled ventilation
group 1 starts with volume controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to pressure controlled ventilation after letting washout we take three consecutive measurements at pressure controlled ventilation and we will repeat this protocol during surgery
Other: Group 2
group 2 starts with pressure controlled ventilation
group 2 starts with pressure controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to volume controlled ventilation after letting washout we take three consecutive measurements at volume controlled ventilation and we will repeat this protocol during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calculation of mechanical power changes in two different ventilation modes
Time Frame: change from at the beginning of surgery till the end of surgery
mechanical power will be calculated using the Van der Meijden's formula for pressure support ventilation and Gattinoni's formula for volume controlled ventilation and two mechanical powers will be compared
change from at the beginning of surgery till the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pulmonary complications
Time Frame: post-operative 7 days
postoperative pulmonary complication including pneumonia, acute lung injury, respiratory failure requiring reintubation
post-operative 7 days
hospitalisation time
Time Frame: up to 20 days
up to 20 days
up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Istanbul University, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

November 5, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Estimate)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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