PneumoperitoneumNCT02690688
Intra-abdominal Pressure and Dynamic Preload Variables
An observational study of Pneumoperitoneum, run by University of Luebeck at 1 site in Germany.
Trial summary
Dynamic preload variables like pulse-pressure and stroke volume variation may be used to predict fluid responsiveness in patients during controlled ventilation. Previous work has shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic preload parameters, suggestive of a fluid deficit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- determination of dynamic preload variables
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Jul 2017
- Phase
- Observational
- 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
Study population: Patients with the need of an abdominal operation. According operation technique patients gets assigned to one of the groups. In- and exculsion criteria are given below.
Who may be able to join
- ASA I-III patient
- Signed agreement
- Surgical procedure with open abdomen surgery or pneumperitoneum
- Age > 18 Years
- Intubation
Who cannot join
- BMI ≥ 35 kg/m2
- Need for catecholamines
- Cardiac arrhythmia
- Fluid resuscitation during measurements
- Ongoing periduralcatheter-therapy
- Missing agreement
- Disposition for MH
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University of Luebeck
Lübeck, 23568
About this study
Official title: The Influence of Pneumoperitoneum and Open Abdominal Surgery on Dynamic Preload Variables
Dynamic preload variables like pulse-pressure and stroke volume variation may be used to predict fluid responsiveness in patients during controlled ventilation. Previous work has shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic preload parameters, suggestive of a fluid deficit - despite fluid status had not changed [van Lavieren M 2014].
The results of this study are limited by the fact that a non-invasive and uncalibrated hemodynamic monitoring system (Nexfin™) was used.
The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive surgical procedures with pneumoperitoneum.
Read the detailed description
Hemodynamic monitoring is an essential part of modern anesthesia. Establishing and maintaining normovolemia during surgery is of high clinical relevance. Various studies suggest that dynamic preload parameters like stroke volume variation (SVV) and pulse pressure variation (PVV) are superior for interpretation and management of fluid status than static parameters like central venous pressure (CVP). Consequently, dynamic preload parameters have been integrated in recent guidelines for hemodynamic and fluid management.
Animal studies have shown reliable results for SVV and PVV to discriminate fluid-responder from non-responders if intraabdominal pressure is increased [Jacques D 2011]. In contrast to these findings, van Lavieren and colleagues have shown an inappropriate increase in measured dynamic preload parameters upon opening the abdomen using a non-invasive and uncalibrated system (Nexfin™). The present study thus aims to determine the effects of changes in abdominal pressure on dynamic preload parameters (PPV and SVV) (primary objective) employing an established invasive hemodynamic monitoring tool (Vigileo®, Edwards Lifescience) during open abdominal surgery as well as in minimal invasive surgical procedures using pneumoperitoneum.
Secondary objective is the effect of changes of cerebral oximetry readings during open and laparoscopic procedures and their relation to changes in cardiac index.
Elective ASA I-III patients scheduled for open and laparoscopic abdominal surgery will be enrolled according the planned operative procedure (open abdominal surgery or minimal invasive surgical procedures using pneumoperitoneum) and assignment. 60 patients (30/group) will be included according to a sample size calculation based on the data by van Lavieren.
Prior to induction of anesthesia an invasive blood pressure monitoring (radial artery) will be established and connected to a Vigileo® monitor (Edwards Lifescience). Additionally, bilateral optodes for the monitoring of cerebral oxygenation will be applied (INVOS, Somanetics). Ventilation, anesthesia and fluid management will be standardized.
Hemodynamic variables will be recorded prior to induction of anesthesia, after anesthesia was induced, and at the initial time point of pneumoperitoneum/open abdomen.
- Conditions
- Pneumoperitoneum
- Being tested
- determination of dynamic preload variables
- Keywords
- Pulse Pressure Variation, NIRS, Pneumoperitoneum, Abdominal surgery
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination of dynamic preload variablesDevice
| Study group | Role | What they receive |
|---|---|---|
| Pneumoperitoneum | Patients scheduled for laparoscopic (minimal invasive) abdominal surgery supported by pneumoperitoneum. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience Receives: Device: determination of dynamic preload variables | |
| Open Surgery | Patients scheduled for conventional (open) abdominal surgery. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience Receives: Device: determination of dynamic preload variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters
Measured: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
Secondary outcomes (2)
Influence of pneumoperitoneum or open abdominal surgery on cerebral oxymetry
Measured: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
Correlation of cerebral oxymetry and cadiac index in pneumoperitoneum or open abdominal surgery
Measured: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Heringlake, University of Luebeck
- Investigators
- Matthias Heringlake, MD, Principal investigator, Professor of Anesthesiology, Deputy Director Cardiac Anesthesia, Dept. of Anesthesiology University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690688
- Sponsor's protocol ID
- HL-2016-Monitoring
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
van Lavieren M, Veelenturf J, Hofhuizen C, van der Kolk M, van der Hoeven J, Pickkers P, Lemson J, Lansdorp B. Dynamic preload indicators decrease when the abdomen is opened. BMC Anesthesiol. 2014 Oct 14;14:90. doi: 10.1186/1471-2253-14-90. eCollection 2014.
PubMed 25337036Jacques D, Bendjelid K, Duperret S, Colling J, Piriou V, Viale JP. Pulse pressure variation and stroke volume variation during increased intra-abdominal pressure: an experimental study. Crit Care. 2011;15(1):R33. doi: 10.1186/cc9980. Epub 2011 Jan 19.
PubMed 21247472
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pneumoperitoneum and Open Abdominal Surgery on Dynamic Preload Variables
- ClinicalTrials.gov ID
- NCT02690688
- Acronym / sponsor ID
- HL-2016-Monitoring
- Conditions
- Pneumoperitoneum
- Keywords
- Pulse Pressure Variation, NIRS, Pneumoperitoneum, Abdominal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 24 Feb 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.
Dynamic preload variables like pulse-pressure and stroke volume variation may be used to predict fluid responsiveness in patients during controlled ventilation. Previous work has shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic preload parameters, suggestive of a fluid deficit - despite fluid status had not changed [van Lavieren M 2014].
The results of this study are limited by the fact that a non-invasive and uncalibrated hemodynamic monitoring system (Nexfin™) was used.
The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive surgical procedures with pneumoperitoneum.
Detailed description
Hemodynamic monitoring is an essential part of modern anesthesia. Establishing and maintaining normovolemia during surgery is of high clinical relevance. Various studies suggest that dynamic preload parameters like stroke volume variation (SVV) and pulse pressure variation (PVV) are superior for interpretation and management of fluid status than static parameters like central venous pressure (CVP). Consequently, dynamic preload parameters have been integrated in recent guidelines for hemodynamic and fluid management.
Animal studies have shown reliable results for SVV and PVV to discriminate fluid-responder from non-responders if intraabdominal pressure is increased [Jacques D 2011]. In contrast to these findings, van Lavieren and colleagues have shown an inappropriate increase in measured dynamic preload parameters upon opening the abdomen using a non-invasive and uncalibrated system (Nexfin™). The present study thus aims to determine the effects of changes in abdominal pressure on dynamic preload parameters (PPV and SVV) (primary objective) employing an established invasive hemodynamic monitoring tool (Vigileo®, Edwards Lifescience) during open abdominal surgery as well as in minimal invasive surgical procedures using pneumoperitoneum.
Secondary objective is the effect of changes of cerebral oximetry readings during open and laparoscopic procedures and their relation to changes in cardiac index.
Elective ASA I-III patients scheduled for open and laparoscopic abdominal surgery will be enrolled according the planned operative procedure (open abdominal surgery or minimal invasive surgical procedures using pneumoperitoneum) and assignment. 60 patients (30/group) will be included according to a sample size calculation based on the data by van Lavieren.
Prior to induction of anesthesia an invasive blood pressure monitoring (radial artery) will be established and connected to a Vigileo® monitor (Edwards Lifescience). Additionally, bilateral optodes for the monitoring of cerebral oxygenation will be applied (INVOS, Somanetics). Ventilation, anesthesia and fluid management will be standardized.
Hemodynamic variables will be recorded prior to induction of anesthesia, after anesthesia was induced, and at the initial time point of pneumoperitoneum/open abdomen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumoperitoneum | – | Device: determination of dynamic preload variablesPatients scheduled for laparoscopic (minimal invasive) abdominal surgery supported by pneumoperitoneum. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience |
| Open Surgery | – | Device: determination of dynamic preload variablesPatients scheduled for conventional (open) abdominal surgery. Hemodynamic monitoring will be performed using Vigileo® monitor, Edwards Lifescience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the need of an abdominal operation. According operation technique patients gets assigned to one of the groups. In- and exculsion criteria are given below.
Key inclusion criteria (5 listed)
- ASA I-III patient
- Signed agreement
- Surgical procedure with open abdomen surgery or pneumperitoneum
- Age > 18 Years
- Intubation
Key exclusion criteria (7 listed)
- BMI ≥ 35 kg/m2
- Need for catecholamines
- Cardiac arrhythmia
- Fluid resuscitation during measurements
- Ongoing periduralcatheter-therapy
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 |
|---|---|---|
| determination of dynamic preload variables | Device | Open Surgery, Pneumoperitoneum |
Primary outcome
Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters
Time frame: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
2 secondary outcomes
Influence of pneumoperitoneum or open abdominal surgery on cerebral oxymetry
Time frame: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
Correlation of cerebral oxymetry and cadiac index in pneumoperitoneum or open abdominal surgery
Time frame: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Background: PubMed 25337036van Lavieren M, Veelenturf J, Hofhuizen C, van der Kolk M, van der Hoeven J, Pickkers P, Lemson J, Lansdorp B. Dynamic preload indicators decrease when the abdomen is opened. BMC Anesthesiol. 2014 Oct 14;14:90. doi: 10.1186/1471-2253-14-90. eCollection 2014.
- Background: PubMed 21247472Jacques D, Bendjelid K, Duperret S, Colling J, Piriou V, Viale JP. Pulse pressure variation and stroke volume variation during increased intra-abdominal pressure: an experimental study. Crit Care. 2011;15(1):R33. doi: 10.1186/cc9980. Epub 2011 Jan 19.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Heringlake, MD principal investigator
Professor of Anesthesiology, Deputy Director Cardiac Anesthesia, Dept. of Anesthesiology University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum, run by University of Luebeck at 1 site in Germany.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Feb 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Heringlake, MD (0049/451/500-2772, matthias.heringlake@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of pneumoperitoneum or open abdominal surgery on dynamic preload parameters (time frame: Mesurements during one minute after induction of pneumoperitoneum or open abdominal surgery). 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 NCT02690688, which also lists 2 linked publications.
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 24 Feb 2016.