Short Time Low PEEP Challenge and Mini Fluid Challenge

NCT05419570 | Completed

• 1 other identifier: 2021.01.31
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intraoperative Care; Fluid Responsiveness

Keywords

Intraoperative monitoring; fluid therapy

Outcome Measures

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

  one day

Study Arms (1)

Patients Undergoing Pancreaticoduodenectomy

Other: Fluid Loading

Interventions

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.

Patients Undergoing Pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pancreaticoduodenectomy

You may qualify if:

• Patients undergoing pancreaticoduodenectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (2)

Başakşehir Çam adn Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Abdullah T, Gokduman HC, Bahar Ozbey N, Sarban O, Ali A, Gumus Ozcan F. Comparison of the ability of short time low PEEP challenge and mini fluid challenge to predict fluid responsiveness in patients undergoing open pancreaticoduodenectomy: an observational cohort study. Eur Rev Med Pharmacol Sci. 2024 Jun;28(12):3860-3870. doi: 10.26355/eurrev_202406_36463.

  PMID: 38946384 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: June 20, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

TU (2)