Colorectal SurgeryPVIvDopplerNCT02142816
Fluid Requirement During Surgery PVI v Doppler
A study testing Doppler and PVI' in people with Colorectal Surgery and Major Abdominal Surgery, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Major Abdominal Surgery
- What is being tested?
- Doppler and PVI'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Mar 2014
- 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
- Major abdominal surgery
- Anaerobic Threshold >11 ml O2/kg/min
- VE/VCO2 <34 OR
- Low risk according to Consultant anaesthetist
Who cannot join
- Patients age less than 18
- Patient refused consent
- Patient unable to give consent
- Patient has had <24hrs to consider the Patient information Sheet
- Contraindication to Doppler Probe being inserted
- Emergency Procedure
Show all 12Show fewer
- Patient has a ASA Grade 5
- Patient is receiving dialysis treatment
- Patient has a known hypersensitivity to hydroxyethyl starch or gelatin solutions
- Patients with renal failure with oliguria or anuria - not related to hypovolaemia
- Patients with a previously diagnosed dysrhythmia
- Patients who weight >100kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Assessment of Fluid Requirement During Surgery: a Comparison of Oesophageal Doppler and Pleth Variability Index
Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.
Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.
Read more
The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.
The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur
- Conditions
- Colorectal Surgery, Major Abdominal Surgery
- Being tested
- Doppler, PVI'
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopplerDevice
Fluid therapy guided by doppler
PVI'Other
Fluid therapy guided by PVI
| Study group | Role | What they receive |
|---|---|---|
| Doppler | Active comparator | Fluid directed by oesophageal doppler Receives: Device: Doppler |
| PVI | Active comparator | Fluid therapy directed by Pleth Variability Index Receives: Other: PVI' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between fluid volumes administered in the intra-operative period
Measured: End of operation
Secondary outcomes (3)
Difference in 24 hour fluid balance
Measured: 24 hours
Post-operative morbiditiy survey
Measured: 7 days
Biochemical Markers of Tissue Perfusion
Lactate and Base Excess
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Yates, MB ChB, Principal investigator, York Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142816
- Sponsor's protocol ID
- YOR-A02089
- Acronym
- PVIvDoppler
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Fluid Requirement During Surgery: a Comparison of Oesophageal Doppler and Pleth Variability Index
- ClinicalTrials.gov ID
- NCT02142816
- Acronym / sponsor ID
- PVIvDoppler / YOR-A02089
- Conditions
- Colorectal Surgery, Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 May 2014 (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.
Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.
Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.
The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.
The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doppler | Active comparator | Device: DopplerFluid directed by oesophageal doppler |
| PVI | Active comparator | Other: PVI'Fluid therapy directed by Pleth Variability Index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major abdominal surgery
- Anaerobic Threshold >11 ml O2/kg/min
- VE/VCO2 <34 OR
- Low risk according to Consultant anaesthetist
Key exclusion criteria (12 listed)
- Patients age less than 18
- Patient refused consent
- Patient unable to give consent
- Patient has had <24hrs to consider the Patient information Sheet
- Contraindication to Doppler Probe being inserted
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 |
|---|---|---|
| DopplerFluid therapy guided by doppler | Device | Doppler |
| PVI'Fluid therapy guided by PVI | Other | PVI |
Primary outcome
Difference between fluid volumes administered in the intra-operative period
Time frame: End of operation
3 secondary outcomes
Difference in 24 hour fluid balance
Time frame: 24 hours
Post-operative morbiditiy survey
Time frame: 7 days
Biochemical Markers of Tissue Perfusion
Time frame: 24 hours
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 May 2014.
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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.
David Yates, MB ChB principal investigator
York Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler and PVI' in people with Colorectal Surgery and Major Abdominal Surgery, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 12 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 May 2014. 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 United Kingdom. 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 fluid volumes administered in the intra-operative period (time frame: End of operation). 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 20 May 2014.