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NCT05419570 Clinical Trial

Short Time Low PEEP Challenge and Mini Fluid Challenge

Fluid Responsiveness Clinical Trial

Official title:
Ability of Short Time Low PEEP Challenge and Mini Fluid Challenge to Predict Fluid Responsiveness During Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05419570
Other study ID # 2021.01.31
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2022
Est. completion date October 5, 2022

Study information
Verified date October 2022
Source Istanbul Saglik Bilimleri University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Optimizing fluid therapy is one of the main concerns for anesthesiologists during the intraoperative period. It becomes even more important in high-risk long lasting surgeries as pancreaticoduodenectomy. Therefore evaluating fluid responsiveness prior to fluid loading is highly recommended. To the best of our knowledge there is no study comparing the abilities short time low PEEP challenge and mini fluid challenge in predicting fluid responsiveness.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date October 5, 2022
Est. primary completion date October 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients undergoing pancreaticoduodenectomy Exclusion Criteria: - Body mass index (BMI) > 35 kg / m2 - any ventricular dysfunction - Crs < 35 ml / cmH2O - valvular heart disease - ASA score > 3 - cardiac arrhythmia - history of lung disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fluid Loading
Hemodynamic and ventilatory parameters will be recorded at five time points (T1 - T5). After baseline meausrements (T1), additional 5 cmH2O PEEP will be applied to patients for 30 seconds (short time low peep challenge, SLPC). Prior to PEEP lowering T2 measurement will be performed. T3 measurement will be performed one minute after PEEP is decreased to its initial value and will be recorded as the second baseline. Thereafter, 100 ml isotonic saline will be infused over one minute (MFC). T4 measurement will be performed one minute after MFC is completed,. Lastly, T5 measurement will be performed three minutes after additional 400 ml of isotonic saline is infused within 10 minutes to complete 500 ml of fluid loading.

Locations
Country Name City State
Turkey Basaksehir Çam adn Sakura City Hospital Istanbul
Turkey Basaksehir Çam and Sakura City Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference between the abilities of two methods to predict fluid responsiveness defined as an increase in stroke volume index >15% after fluid loading Difference between the area under reciever operating characterisitcs curve of two methods one day
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