SurgeryPhase 2NCT02709252
Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
A Phase 2 study testing PVI and deltaPP after trendelenburg position change in people with Surgery, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery
- What is being tested?
- PVI and deltaPP after trendelenburg position change
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- American Society of Anesthesiologists (ASA) score I-II
- scheduled for elective abdominal laparoscopic surgery
- with written informed consent
- more than 18 years
- Body Mass Index < 40 kg.m-2
- no supraventricular arrhythmias
- no heart failure with ejection fraction <25 %
- no peripheral vascular
- no severe respiratory disease
- no end stage renal failure (creatinine clearance <30ml/min).
Trial locations and contacts
1 site in 1 country.
About this study
Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.
- Conditions
- Surgery
- Being tested
- PVI and deltaPP after trendelenburg position change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI and deltaPP after trendelenburg position changeDevice
Comparison of hemodynamic parameters during surgery after position change
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Only one cohort is included with comparisons of two different hemodynamic parameters Receives: Device: PVI and deltaPP after trendelenburg position change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth variability index (in %)
Before/after trendelenburg positioning in laparoscopic surgery
Measured: 5 minutes
Pulse Pressure variation (deltaPP) (in %)
Before/after trendelenburg positioning in laparoscopic surgery
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forget Patrice, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709252
- Sponsor's protocol ID
- 201134
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.
- ClinicalTrials.gov ID
- NCT02709252
- Acronym / sponsor ID
- 201134
- Conditions
- Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- First posted
- 16 Mar 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.
Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Device: PVI and deltaPP after trendelenburg position changeOnly one cohort is included with comparisons of two different hemodynamic parameters |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PVI and deltaPP after trendelenburg position changeComparison of hemodynamic parameters during surgery after position change | Device | Cohort |
Primary outcome
Pleth variability index (in %)
Time frame: 5 minutes
Before/after trendelenburg positioning in laparoscopic surgery
Pulse Pressure variation (deltaPP) (in %)
Time frame: 5 minutes
Before/after trendelenburg positioning in laparoscopic surgery
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 16 Mar 2016.
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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?
A Phase 2 study testing PVI and deltaPP after trendelenburg position change in people with Surgery, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pleth variability index (in %) (time frame: 5 minutes). 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 16 Mar 2016.