Neurosurgery in Sitting PositionNCT02000570
Dynamic Preload Indicators in Sitting Position
A study testing Sitting position (neurosurgery) in people with Neurosurgery in Sitting Position, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgery in Sitting Position
- What is being tested?
- Sitting position (neurosurgery)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2013to 11 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurosurgery in sitting position
- age > 18
Who cannot join
- arrhythmias
- severe heart failure
- severe lung disease
- contraindications to esophageal Doppler monitoring probe insertion (i.e. esophageal weakness)
- renal failure
Trial locations and contacts
1 site in 1 country.
France1 site
Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer
Bron, 69500
About this study
Official title: Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position
Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.
Read the detailed description
The primary objective is to determine PPV, SVV and PVI thresholds for which patients respond to fluid challenge in sitting position.
The secondary objectives are to determine variations of PPV, SVV and PVI measures before and after positioning in sitting position, and to compare these values to each other.
- Conditions
- Neurosurgery in Sitting Position
- Being tested
- Sitting position (neurosurgery)
- Keywords
- sitting position, PPV, SVV, PVI, fluid challenge, preload indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting position (neurosurgery)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| sitting position | Experimental | Not described Receives: Procedure: Sitting position (neurosurgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV (Pulse pressure variation)
PPV is derived from arterial pressure waveforms and is displayed in real -time on Intellivue MP70 Philips monitors.
Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
Measured: 3 minutes before and after fluid challenge in sitting position
SVV (Stroke volume variation)
SVV is derived from arterial pressure waveforms and is displayed in real -time on Vigileo Edwards Lifesciences monitors.
Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
Measured: 3 minutes before and after positioning in sitting position
PVI (Plethysmographic variability index)
PVI is derived from plethysmography waveforms and is displayed in real-time on Radical 7 Masimo monitors.
Value of each indicator will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
Measured: 3 minutes before and after positioning in sitting position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study start17 Oct 2013
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgery in Sitting PositionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000570
- Sponsor's protocol ID
- 2013.813
- Other IDs
- 2013-A00937-38
- Status last verified
- Sep 2018
- First submitted
- 27 Nov 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position
- ClinicalTrials.gov ID
- NCT02000570
- Acronym / sponsor ID
- 2013.813
- Conditions
- Neurosurgery in Sitting Position
- Keywords
- sitting position, PPV, SVV, PVI, fluid challenge, preload indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Oct 2013 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 4 Dec 2013 (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.
Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.
Detailed description
The primary objective is to determine PPV, SVV and PVI thresholds for which patients respond to fluid challenge in sitting position.
The secondary objectives are to determine variations of PPV, SVV and PVI measures before and after positioning in sitting position, and to compare these values to each other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sitting position | Experimental | Procedure: Sitting position (neurosurgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- neurosurgery in sitting position
- age > 18
Key exclusion criteria (5 listed)
- arrhythmias
- severe heart failure
- severe lung disease
- contraindications to esophageal Doppler monitoring probe insertion (i.e. esophageal weakness)
- renal failure
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 |
|---|---|---|
| Sitting position (neurosurgery) | Procedure or surgery | sitting position |
Primary outcome
PPV (Pulse pressure variation)
Time frame: 3 minutes before and after fluid challenge in sitting position
PPV is derived from arterial pressure waveforms and is displayed in real -time on Intellivue MP70 Philips monitors. Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
SVV (Stroke volume variation)
Time frame: 3 minutes before and after positioning in sitting position
SVV is derived from arterial pressure waveforms and is displayed in real -time on Vigileo Edwards Lifesciences monitors. Value will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
PVI (Plethysmographic variability index)
Time frame: 3 minutes before and after positioning in sitting position
PVI is derived from plethysmography waveforms and is displayed in real-time on Radical 7 Masimo monitors. Value of each indicator will be recorded before fluid challenge. Responders will be assessed by esophageal Doppler.
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 5 Sep 2018.
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 Sitting position (neurosurgery) in people with Neurosurgery in Sitting Position, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 5 Sep 2018. 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 France. 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: 3 minutes before and after fluid challenge in sitting position). 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?
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 5 Sep 2018.