Intraoperative CareNCT05419570
Short Time Low PEEP Challenge and Mini Fluid Challenge
An observational study of Intraoperative Care and Fluid Responsiveness, run by Istanbul Saglik Bilimleri University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Care, Fluid Responsiveness
- What is being tested?
- Fluid Loading
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Jun 2022to 5 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing pancreaticoduodenectomy
Who may be able to join
- Patients undergoing pancreaticoduodenectomy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Başakşehir Çam adn Sakura City Hospital
Istanbul
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
Official title: Ability of Short Time Low PEEP Challenge and Mini Fluid Challenge to Predict Fluid Responsiveness During Pancreaticoduodenectomy
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
- Being tested
- Fluid Loading
- Keywords
- Intraoperative monitoring, fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid LoadingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Pancreaticoduodenectomy | Not described Receives: Other: Fluid Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start20 Jun 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419570
- Sponsor's protocol ID
- 2021.01.31
- Status last verified
- Oct 2022
- First submitted
- 10 Jun 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38946384
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Short Time Low PEEP Challenge and Mini Fluid Challenge to Predict Fluid Responsiveness During Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05419570
- Acronym / sponsor ID
- 2021.01.31
- Conditions
- Intraoperative Care, Fluid Responsiveness
- Keywords
- Intraoperative monitoring, fluid therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Pancreaticoduodenectomy | – | Other: Fluid Loading |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pancreaticoduodenectomy
Key inclusion criteria (1 listed)
- Patients undergoing pancreaticoduodenectomy
Key exclusion criteria (7 listed)
- Body mass index (BMI) > 35 kg / m2
- any ventricular dysfunction
- Crs < 35 ml / cmH2O
- valvular heart disease
- ASA score > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid LoadingHemodynamic 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. | Other | Patients Undergoing Pancreaticoduodenectomy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 38946384Abdullah 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.
- Individual participant dataSharing planned: Undecided
Related trials for Intraoperative Care
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
Wearable Ultrasound for Cardiac Monitoring During Surgery and in Intensive Care
Cardiovascular Diseases
Recruiting
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy
Surgical Stress Response, Inflammation
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Not yet recruiting
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension
Intra-operative Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Care and Fluid Responsiveness, run by Istanbul Saglik Bilimleri University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.