- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05690867
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
Status
Completed
Conditions
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.
Sponsor
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.
General Publications
- Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
- van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
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
Other Study ID Numbers
- 2021-2081
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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