Elective Posterior Lumbar Spinal Fusion for Spinal StenosisNCT02826889
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table
A study testing Philips Intelivue MP70 monitor and Pleth Variability Index (PVI) in people with Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis and Spondylolisthesis, run by Yonsei University at 1 site in South Korea.
Trial summary
Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Spondylolisthesis, Spinal Fractures
- What is being tested?
- Philips Intelivue MP70 monitor and Pleth Variability Index (PVI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2016to 27 Jul 2017
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table
Who cannot join
- Patient refusal
- Patients that are not normal sinus rhythm on preoperative ECG
- Patients with moderate~severe cardiac valve disease
- Patients with an ejection fraction under 50%
- Significant lung disease
- Obesity (BMI>35kg/m2)
- Patients with contraindications to esophageal doppler probe insertion
- Illiterate patients or foreigners
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.
- Conditions
- Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Spondylolisthesis, Spinal Fractures, Scoliosis or Tumors
- Being tested
- Philips Intelivue MP70 monitor, Pleth Variability Index (PVI)
- Keywords
- Fluid responsiveness, corrected flow time, pleth variability index, prone position
- Medical subject headings
- Spondylolisthesis, Spinal Fractures, Scoliosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Intelivue MP70 monitorDevice
Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.
Pleth Variability Index (PVI)Device
PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.
| Study group | Role | What they receive |
|---|---|---|
| Fluid loading group | Experimental | Not described Receives: Device: Philips Intelivue MP70 monitor; Device: Pleth Variability Index (PVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Pressure Variation (PPV)
Fluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.
Measured: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position
Pleth Variability Index (PVI)
Measured: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start24 May 2016
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Posterior Lumbar Spinal Fusion for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826889
- Sponsor's protocol ID
- 4-2016-0189
- Status last verified
- Sep 2017
- First submitted
- 6 Jul 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table
- ClinicalTrials.gov ID
- NCT02826889
- Acronym / sponsor ID
- 4-2016-0189
- Conditions
- Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Spondylolisthesis, Spinal Fractures, Scoliosis or Tumors
- Keywords
- Fluid responsiveness, corrected flow time, pleth variability index, prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 May 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid loading group | Experimental | Device: Philips Intelivue MP70 monitor, Device: Pleth Variability Index (PVI) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table
Key exclusion criteria (8 listed)
- Patient refusal
- Patients that are not normal sinus rhythm on preoperative ECG
- Patients with moderate~severe cardiac valve disease
- Patients with an ejection fraction under 50%
- Significant lung disease
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 |
|---|---|---|
| Philips Intelivue MP70 monitorPhilips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters. | Device | Fluid loading group |
| Pleth Variability Index (PVI)PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor. | Device | Fluid loading group |
Primary outcome
Pulse Pressure Variation (PPV)
Time frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position
Fluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.
Pleth Variability Index (PVI)
Time frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position
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 2 Oct 2017.
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?
A study testing Philips Intelivue MP70 monitor and Pleth Variability Index (PVI) in people with Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis and Spondylolisthesis, run by Yonsei University at 1 site in South Korea.
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 8 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 2 Oct 2017. 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 South Korea. 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?
Pulse Pressure Variation (PPV) (time frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.