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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05690867
Other study ID # 2021-2081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2022
Est. completion date December 5, 2022

Study information

Verified date January 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 5, 2022
Est. primary completion date November 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes
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
Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes
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

Locations

Country Name City State
Turkey Istanbul University, Department of Anesthesiology Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary calculation of mechanical power changes in two different ventilation modes 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 postoperative pulmonary complications postoperative pulmonary complication including pneumonia, acute lung injury, respiratory failure requiring reintubation post-operative 7 days
Secondary hospitalisation time up to 20 days up to 20 days
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