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OpenTrials
Completed

NCT Number: NCT05419570

Short Time Low PEEP Challenge and Mini Fluid Challenge

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam adn Sakura City Hospital, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Loading

Other

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.

Primary outcomes

  1. Difference between the abilities of two methods to predict fluid responsiveness defined as an increase in stroke volume index >15% after fluid loading

    Time frame: one day

    Difference between the area under reciever operating characterisitcs curve of two methods

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2022
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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