AnesthesiaNCT05401526
Fluid Responsiveness in Prone Position
An observational study of Anesthesia and Spine Fusion, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Spine Fusion
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2022to 5 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing spine surgery in prone position
Who may be able to join
- Patients undergoing spine surgery in prone position
- Age≥ 18 years
- Elective surgery
Who cannot join
- American Society of Anesthesiology physical status over III
- Valvular heart disease
- Any ventricular dysfunction
- Preoperative arrythmias
- Preoperative hemodynamic instability
- Preoperative uncontrolled hypertension
Show all 9Show fewer
- Preoperative uncontrolled diabetes mellitus
- History of lung disease
- Morbid obesity (Body mass index ≥ 40 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ability of Challenge With 5 cmH2O of Positive End-expiratory Pressure to Predict Fluid Responsiveness in Prone Position: An Observational Study
We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position. First measurement (T1, First baseline) will be performed in the prone position after performing tracheal intubation and confirming hemodynamic stability (defined as mean arterial pressure <10% for 3 minutes). After the T1 measurement, additional 5 cmH2O PEEP (Positive end-expiratory pressure) will be applied for 30 seconds which will be called as "short term low PEEP challenge (SLPC)". At the end of the SLPC and prior to PEEP lowering, T2 measurement will be performed and recorded. After the T2 measurement, PEEP will be decreased to the initial value (5 cmH2O) and three minutes later, a second baseline (T3) measurement will be performed. Thereafter, 500 ml isotonic saline will be loaded in 10 minutes. T4 measurement will be performed again three minutes after volume loading. All of the measurements will be completed before surgery start and surgical stimulus. Patients exhibiting an increase in stroke volume index more than 15% after fluid loading (between T3 and T4) will be classified as volume responders. Absolute pulse pressure variation change due to SLPC, Absolute Stroke volume variation change due to SLPC, stroke volume index percentage change due to SLPC, and stroke volume index percentage change after fluid loading will be calculated and compared. Our aim is to observe if short term low PEEP challenge has the ability to predict fluid responsiveness better than pulse pressure variation and stroke volume variation for patients operated in prone position.
- Conditions
- Anesthesia, Spine Fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of stroke volume index percentage change after SLPC
Stroke volume index percentage change after SLPC means " [(SVIT2 - SVIT1) / SVIT1] x 100".
Measured: Up to 30 minutes
Verification of stroke volume index percentage change after fluid loading
Stroke volume variation and pulse pressure variation values will be measured at second baseline (T3) and after fluid loading (T4).
Fluid responsive patients means " stroke volume index increase after fluid loading ≥ 15%".
In another explanation; [(SVIT4- SVIT3)/ SVI (T3)]x100 ≥ 15% means fluid responsive patients.
Measured: Up to 30 minutes
Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC
Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve)
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 Jun 2022
- Primary completion5 Aug 2022
- Study completion5 Aug 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 AnesthesiaStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Sertaç Bingül, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401526
- Sponsor's protocol ID
- 2022/629
- Status last verified
- Aug 2022
- First submitted
- 26 May 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ali A, Aygun E, Abdullah T, Bolsoy-Deveci S, Orhan-Sungur M, Canbaz M, Ozkan Akinci I. A challenge with 5 cmH2O of positive end-expiratory pressure predicts fluid responsiveness in neurosurgery patients with protective ventilation: an observational study. Minerva Anestesiol. 2019 Nov;85(11):1184-1192. doi: 10.23736/S0375-9393.19.13721-2. Epub 2019 Jun 17.
PubMed 31213047
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Challenge With 5 cmH2O of Positive End-expiratory Pressure to Predict Fluid Responsiveness in Prone Position: An Observational Study
- ClinicalTrials.gov ID
- NCT05401526
- Acronym / sponsor ID
- 2022/629
- Conditions
- Anesthesia, Spine Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 2 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.
We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position. First measurement (T1, First baseline) will be performed in the prone position after performing tracheal intubation and confirming hemodynamic stability (defined as mean arterial pressure <10% for 3 minutes). After the T1 measurement, additional 5 cmH2O PEEP (Positive end-expiratory pressure) will be applied for 30 seconds which will be called as "short term low PEEP challenge (SLPC)". At the end of the SLPC and prior to PEEP lowering, T2 measurement will be performed and recorded. After the T2 measurement, PEEP will be decreased to the initial value (5 cmH2O) and three minutes later, a second baseline (T3) measurement will be performed. Thereafter, 500 ml isotonic saline will be loaded in 10 minutes. T4 measurement will be performed again three minutes after volume loading. All of the measurements will be completed before surgery start and surgical stimulus. Patients exhibiting an increase in stroke volume index more than 15% after fluid loading (between T3 and T4) will be classified as volume responders. Absolute pulse pressure variation change due to SLPC, Absolute Stroke volume variation change due to SLPC, stroke volume index percentage change due to SLPC, and stroke volume index percentage change after fluid loading will be calculated and compared. Our aim is to observe if short term low PEEP challenge has the ability to predict fluid responsiveness better than pulse pressure variation and stroke volume variation for patients operated in prone position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing spine surgery in prone position
Key inclusion criteria (3 listed)
- Patients undergoing spine surgery in prone position
- Age≥ 18 years
- Elective surgery
Key exclusion criteria (9 listed)
- American Society of Anesthesiology physical status over III
- Valvular heart disease
- Any ventricular dysfunction
- Preoperative arrythmias
- Preoperative hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Verification of stroke volume index percentage change after SLPC
Time frame: Up to 30 minutes
Stroke volume index percentage change after SLPC means " [(SVIT2 - SVIT1) / SVIT1] x 100".
Verification of stroke volume index percentage change after fluid loading
Time frame: Up to 30 minutes
Stroke volume variation and pulse pressure variation values will be measured at second baseline (T3) and after fluid loading (T4). Fluid responsive patients means " stroke volume index increase after fluid loading ≥ 15%". In another explanation; [(SVIT4- SVIT3)/ SVI (T3)]x100 ≥ 15% means fluid responsive patients.
Ability of fluid responsiveness prediction with SVV, PPV, and Stroke volume index percentage change after SLPC
Time frame: Up to 30 minutes
Predictive ability of SVI changes after SLPC and fluid loading will be compared by statistical analysis (ROC curve)
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 8 Aug 2022.
- Background: PubMed 31213047Ali A, Aygun E, Abdullah T, Bolsoy-Deveci S, Orhan-Sungur M, Canbaz M, Ozkan Akinci I. A challenge with 5 cmH2O of positive end-expiratory pressure predicts fluid responsiveness in neurosurgery patients with protective ventilation: an observational study. Minerva Anestesiol. 2019 Nov;85(11):1184-1192. doi: 10.23736/S0375-9393.19.13721-2. Epub 2019 Jun 17.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Spine Fusion, run by Istanbul University at 1 site 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 3 inclusion and 9 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Verification of stroke volume index percentage change after SLPC (time frame: Up to 30 minutes). The study lists 3 primary outcomes in all. 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 NCT05401526, 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 8 Aug 2022.