PneumoperitoneumNCT01854307
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
A study testing Pneumoperitoneum and SVV/PPV in people with Pneumoperitoneum, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- Pneumoperitoneum and SVV/PPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Aug 2015
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients >18 years scheduled for robot-assisted prostatectomy
- able to give informed consent
Who cannot join
- Patient with atrial fibrillation or other non-regular rhythm.
- Severe aorta/mitral stenosis
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.
- Conditions
- Pneumoperitoneum
- Being tested
- Pneumoperitoneum and SVV/PPV
- Keywords
- Difference of, measurements, before and after
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum and SVV/PPVProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pneumoperitoneum and SVV/PPV | Experimental | Not described Receives: Procedure: Pneumoperitoneum and SVV/PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of stroke volume variation and pulse pressure variation during pneumoperitoneum
Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum.
Measured: peroperative
Secondary outcomes (2)
Difference in measurements from different methods of minimal cardiac output monitoring.
Measured: peroperative
Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)
Measured: peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2015
Why it stopped: Low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ib Jammer, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854307
- Sponsor's protocol ID
- 2012/1475/REK vest
- Status last verified
- Jan 2016
- First submitted
- 13 May 2013
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
- ClinicalTrials.gov ID
- NCT01854307
- Acronym / sponsor ID
- 2012/1475/REK vest
- Conditions
- Pneumoperitoneum
- Keywords
- Difference of, measurements, before and after
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- First posted
- 15 May 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.
Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumoperitoneum and SVV/PPV | Experimental | Procedure: Pneumoperitoneum and SVV/PPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients >18 years scheduled for robot-assisted prostatectomy
- able to give informed consent
Key exclusion criteria (3 listed)
- Patient with atrial fibrillation or other non-regular rhythm.
- Severe aorta/mitral stenosis
- Not able to give informed consent
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 |
|---|---|---|
| Pneumoperitoneum and SVV/PPV | Procedure or surgery | Pneumoperitoneum and SVV/PPV |
Primary outcome
Change of stroke volume variation and pulse pressure variation during pneumoperitoneum
Time frame: peroperative
Change in PPV/SVV(LiDCO), PPV(Philips) and SVV/CO(TEE) in percent before and after pneumoperitoneum.
2 secondary outcomes
Difference in measurements from different methods of minimal cardiac output monitoring.
Time frame: peroperative
Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)
Time frame: peroperative
Results and safety
The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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 study testing Pneumoperitoneum and SVV/PPV in people with Pneumoperitoneum, run by Haukeland University Hospital at 1 site in Norway.
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 3 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: stopped early, as of the sponsor's last update on 25 Jan 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 Norway. 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 was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
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?
Change of stroke volume variation and pulse pressure variation during pneumoperitoneum (time frame: peroperative). 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 25 Jan 2016.