Elective Posterior Lumbar Spinal FusionNCT01646359
Value of Pulse Pressure Variations and Corrected Flow Time in Esophageal Doppler as a Predictor of Fluid Responsiveness in Prone Position During Spinal Surgery
A study testing 1.Esophageal doppler monitor and 2. philips Intelivue MP70 monitors in people with Elective Posterior Lumbar Spinal Fusion, run by Yonsei University at 1 site in South Korea.
Trial summary
In patients under mechanical ventilation, Usefulness of dynamic indices based on the heart-lung interactions for guiding volume resuscitation has been well validated. Recently, validity of pulse pressure variation (PPV) has been also reported to predict fluid responsiveness. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Elective Posterior Lumbar Spinal Fusion
- What is being tested?
- 1.Esophageal doppler monitor and 2. philips Intelivue MP70 monitors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Feb 2012
- 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective spine surgery
- age : > 20 and < 70, 3. Patients expecting intraoperative blood loss more than 10% of estimated blood volume
Who cannot join
- arrhythmias
- BMI > 30 kg/m2
- valvular heart disease
- left ventricular ejection fraction < 50%
- history of lung disease
- pregnancy
- foreigner
- contraindications to esophageal doppler monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, intra-aortic balloon pump, coarctation of the aorta, and severe coagulopathy)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, Seoul, 120-752
About this study
In patients under mechanical ventilation, Usefulness of dynamic indices based on the heart-lung interactions for guiding volume resuscitation has been well validated. Recently, validity of pulse pressure variation (PPV) has been also reported to predict fluid responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and used as a preload index, and has been reported to predict fluid responsiveness. Prone position caused physiologic and hemodynamic changes and influenced the predictability and cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study, the investigators evaluated the validity of PPV and FTc as predictors for fluid responsiveness in supine and prone position in patients undergoing posterior lumbar spinal fusion
- Conditions
- Elective Posterior Lumbar Spinal Fusion
- Being tested
- 1.Esophageal doppler monitor, 2. philips Intelivue MP70 monitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.Esophageal doppler monitorDevice
Also called 1.CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.
1.Esophageal doppler monitor (CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.)-inserted into the esophagus and positioned approximately 35-40 cm from the teeth. The position of OED prove was confirmed by continuously measuring blood flow velocity in the descending thoracic aorta and focused to find the optimum peak velocity and waveform signal.
2. philips Intelivue MP70 monitorsDevice
Also called 2.intellivue MP70, philips medical Systems, Suresnes, France
2.philips Intelivue MP70 monitors (Intellivue MP70, philips medical Systems, Suresnes, France) -a radial arterial cannula was inserted and arterial pressure waveforms were monitored through Philips Intelivue MP70 monitors. In the monitor, PPVauto was displayed in real-time. It based on automatic detection algorithms, kernel smoothing, and rank-order filters.
| Study group | Role | What they receive |
|---|---|---|
| corrected flow time | Experimental | Not described Receives: Device: 1.Esophageal doppler monitor; Device: 2. philips Intelivue MP70 monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV(Pulse pressure variation)
Measured: 15 minutes after induction of anaesthesia at the supine position
FTc(corrected flow time)
Measured: 15 minutes after induction of anaesthesia at the supine position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 Elective Posterior Lumbar Spinal FusionStudies 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
- 45 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
- NCT01646359
- Sponsor's protocol ID
- 1-2010-0046
- Status last verified
- Jul 2012
- First submitted
- 15 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang SY, Shim JK, Song Y, Seo SJ, Kwak YL. Validation of pulse pressure variation and corrected flow time as predictors of fluid responsiveness in patients in the prone position. Br J Anaesth. 2013 May;110(5):713-20. doi: 10.1093/bja/aes475. Epub 2012 Dec 28.
PubMed 23274783
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Pulse Pressure Variations and Corrected Flow Time in Esophageal Doppler as a Predictor of Fluid Responsiveness in Prone Position During Spinal Surgery
- ClinicalTrials.gov ID
- NCT01646359
- Acronym / sponsor ID
- 1-2010-0046
- Conditions
- Elective Posterior Lumbar Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Jul 2012 (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.
In patients under mechanical ventilation, Usefulness of dynamic indices based on the heart-lung interactions for guiding volume resuscitation has been well validated. Recently, validity of pulse pressure variation (PPV) has been also reported to predict fluid responsiveness. Oesophageal Doppler (OED) allows continuous monitoring of several important hemodynamic variables. Of the OED variables, corrected flow time (FTc) has been evaluated and used as a preload index, and has been reported to predict fluid responsiveness. Prone position caused physiologic and hemodynamic changes and influenced the predictability and cut-off values of SVV and PPV for fluid responsiveness. In this prospective controlled study, the investigators evaluated the validity of PPV and FTc as predictors for fluid responsiveness in supine and prone position in patients undergoing posterior lumbar spinal fusion
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| corrected flow time | Experimental | Device: 1.Esophageal doppler monitor, Device: 2. philips Intelivue MP70 monitors |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing elective spine surgery
- age : > 20 and < 70, 3. Patients expecting intraoperative blood loss more than 10% of estimated blood volume
Key exclusion criteria (8 listed)
- arrhythmias
- BMI > 30 kg/m2
- valvular heart disease
- left ventricular ejection fraction < 50%
- history of 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 |
|---|---|---|
| 1.Esophageal doppler monitorAlso: 1.CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.1.Esophageal doppler monitor (CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.)-inserted into the esophagus and positioned approximately 35-40 cm from the teeth. The position of OED prove was confirmed by continuously measuring blood flow velocity in the descending thoracic aorta and focused to find the optimum peak velocity and waveform signal. | Device | corrected flow time |
| 2. philips Intelivue MP70 monitorsAlso: 2.intellivue MP70, philips medical Systems, Suresnes, France2.philips Intelivue MP70 monitors (Intellivue MP70, philips medical Systems, Suresnes, France) -a radial arterial cannula was inserted and arterial pressure waveforms were monitored through Philips Intelivue MP70 monitors. In the monitor, PPVauto was displayed in real-time. It based on automatic detection algorithms, kernel smoothing, and rank-order filters. | Device | corrected flow time |
Primary outcome
PPV(Pulse pressure variation)
Time frame: 15 minutes after induction of anaesthesia at the supine position
FTc(corrected flow time)
Time frame: 15 minutes after induction of anaesthesia at the supine 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 20 Jul 2012.
- Derived from this study: PubMed 23274783Yang SY, Shim JK, Song Y, Seo SJ, Kwak YL. Validation of pulse pressure variation and corrected flow time as predictors of fluid responsiveness in patients in the prone position. Br J Anaesth. 2013 May;110(5):713-20. doi: 10.1093/bja/aes475. Epub 2012 Dec 28.
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 1.Esophageal doppler monitor and 2. philips Intelivue MP70 monitors in people with Elective Posterior Lumbar Spinal Fusion, 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 2 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 20 Jul 2012. 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?
PPV(Pulse pressure variation) (time frame: 15 minutes after induction of anaesthesia at the supine 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?
On the ClinicalTrials.gov record for NCT01646359, 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 20 Jul 2012.