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CompletedNCT05419570Updated Oct 6, 2022

Short Time Low PEEP Challenge and Mini Fluid Challenge

An observational study in Intraoperative Care and Fluid Responsiveness, sponsored by Istanbul Saglik Bilimleri University. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Istanbul Saglik Bilimleri University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intraoperative Care
  • Fluid Responsiveness

Keywords

  • Intraoperative monitoring
  • fluid therapy
03

In context

Lead sponsor

Istanbul Saglik Bilimleri University is the lead sponsor of 58 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing pancreaticoduodenectomy

Inclusion criteria

  • Patients undergoing pancreaticoduodenectomy

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients Undergoing Pancreaticoduodenectomy

    Other: Fluid Loading

Interventions

  • OtherFluid 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.

06

What researchers measure

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

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

    Time frame: one day

07

Study locations

2 sites
  • Başakşehir Çam adn Sakura City Hospital
    Istanbul, Turkey
  • Başakşehir Çam and Sakura City Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05419570
Lead sponsor
Istanbul Saglik Bilimleri University
Responsible party
Taner Abdullah (Medical Doctor, Istanbul Saglik Bilimleri University) — Principal investigator
First posted
Jun 15, 2022
Start date
Jun 20, 2022
Primary completion
Oct 5, 2022
Completion
Oct 5, 2022
Last update
Oct 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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