PneumoperitoneumSPV-PnPNCT01867814
Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum
A study testing Pneumoperitoneum in people with Pneumoperitoneum and Heart Output Disorder, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Laparoscopic surgery is frequently associated with hemodynamic changes due to pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and occasionally they require active therapeutic interventions or even interruption of the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoperitoneum, Heart Output Disorder
- What is being tested?
- Pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Nov 2016
- 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
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
Who cannot join
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Lady Davis Carmel Medical Center
Haifa, 34362
Reuven Pizov, MD, 97248250625, pizov_reuven@clalit.org.il
Reuven Pizov, MD
About this study
Official title: Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
Laparoscopic surgery is frequently associated with hemodynamic changes due to pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and occasionally they require active therapeutic interventions or even interruption of the surgical procedure.
One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction of venous return and cardiac preload. Although it has been shown repeatedly that waveform variables are good predictors of cardiac output response to volume loading, the prediction hemodynamic response to decrease of preload is more complex.
The investigators hypothesize that waveform variables will predict cardiac output changes resulting from PnP. Particularly, augmented values of waveform variables before PnP will be associated with a larger decrease of cardiac output after establishing PnP.
Read the detailed description
- Goals of the study
- To evaluate hemodynamic changes caused by pneumoperitoneum applied for laparoscopic surgery
- Endpoints
- Blood Pressure: Systolic, Diastolic, Mean (SBP, DBP, MBP)
- Heart Rate (HR)
- Cardiac Output/Index (CO/CI)
- Stroke Volume/Index (SV/SVI)
- Systolic Pressure Variation (SPV)
- Stroke Volume Variation (SVV)
- Plethysmographic Waveform Variation (PWV)
- Inclusion criteria
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA (American Society of Anesthesiologists)class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
- Exclusion criteria
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
- Study course, measurements and analysis
- All study participants will get an explanation and sign on informed consent at least one day prior to the day of surgery
- All study participants will receive standard anesthesia care. All patients will anesthetized intravenously with Fentanyl 2-5 mcg/kg, Propofol 1-2 mg/kg and Rocuronium 0.6-1.0 mg/kg followed by endotracheal intubation. Positive pressure ventilation with tidal volume 8 mL/kg of ideal body weight and respiratory rate 8-12 bpm to achieve end-tidal carbon dioxide of 33-37 mmHg will be applied after intubation. Anesthesia will be maintained with inhalation of Isoflurane (end-expiratory concentration at least 1.2%) in air/O2 (FiO2=0.4). Intraoperative fluid management will include an initial bolus of crystalloid solution (lactated Ringer's solution) at a dose of 7 mL/kg. Arterial blood pressure will be measured continuously through a radial arterial catheter. Pulse oximetry photoplethysmography will be monitored by index finger probe on the same side. Cardiac output will monitored noninvasively by NICOM (Non-invasive cardiac output monitor) that calculates stroke volume variation (SVV) in addition to cardiac output/cardiac index and stroke volume/stroke index
- The study procedure will begin after induction of anesthesia, preparation of the patient for surgery and insertion of the pneumoperitoneum insufflation device. The study procedure will last for 10-15 minutes and will be finished before actual intraperitoneal surgical manipulation begins
- Waveforms will be recorded from the patient monitor and values of NICOM will be noted at baseline before surgical manipulation, at PnP pressure=0 mmHg before gas insufflation but after insertion of peritoneal needle, and after PnP pressure reaches 15 mmHg (routine value for laparoscopic surgery). If after reaching PnP pressure of 15 mmHg CO will decrease by more than 20%, the PnP pressure will be reduced to 10 mmHg and recording of waveforms will be repeated after two minutes
- Standard hemodynamic parameters (heart rate, systolic and diastolic BP) and waveform variables (SPV, PWV) will be measured and calculated offline according to the records
- Parameters measured by NICOM (CO, CI, SV, SVI, SVV) will be noted at baseline (PnP pressure=0 mmHg), after PnP pressure reached 15 mmHg and after PnP pressure decreased till 10 mmHg (if necessary)
- There will be no further follow up of the patients
- We anticipate that there will be a significant number of patients with a reduction of CO by 20% or more after establishment of PnP of 15 mm Hg. We will perform comparisons between waveforms at baseline between those who decrease CO and those who do not. If there will be significant difference in variables at baseline there will be justification to perform ROC analysis to evaluate sensitivity and specificity of these variables to predict decrease in CO. In patients who will have a decrease in CO after PnP of 15 mm Hg we will compare the same variables to those that will be reached at PnP of 10 mmHg. These comparisons can help to understand the mechanisms of CO decrease during PnP
- All of the analysis of the data will be performed after removing all identifying data
- Conditions
- Pneumoperitoneum, Heart Output Disorder
- Being tested
- Pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumoperitoneumProcedure or surgery
Pneumoperitoneum 15 mmHg and 10 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Pneumoperitoneum | Experimental | Patients undergoing laparoscopic surgery Receives: Procedure: Pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output/cardiac index
Cardiac output/cardiac index will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
Measured: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
Secondary outcomes (1)
Systolic pressure variation (SPV)/Pulse pressure variation (PPV)
Systolic pressure variation/Pulse pressure variation will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
Measured: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
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.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pizov Reuven, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867814
- Sponsor's protocol ID
- CMC-12-0133-CTIL
- Acronym
- SPV-PnP
- Status last verified
- Aug 2015
- First submitted
- 27 May 2013
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01867814
- Acronym / sponsor ID
- SPV-PnP / CMC-12-0133-CTIL
- Conditions
- Pneumoperitoneum, Heart Output Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 Jun 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.
Laparoscopic surgery is frequently associated with hemodynamic changes due to pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and occasionally they require active therapeutic interventions or even interruption of the surgical procedure.
One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction of venous return and cardiac preload. Although it has been shown repeatedly that waveform variables are good predictors of cardiac output response to volume loading, the prediction hemodynamic response to decrease of preload is more complex.
The investigators hypothesize that waveform variables will predict cardiac output changes resulting from PnP. Particularly, augmented values of waveform variables before PnP will be associated with a larger decrease of cardiac output after establishing PnP.
Detailed description
- Goals of the study
- To evaluate hemodynamic changes caused by pneumoperitoneum applied for laparoscopic surgery
- Endpoints
- Blood Pressure: Systolic, Diastolic, Mean (SBP, DBP, MBP)
- Heart Rate (HR)
- Cardiac Output/Index (CO/CI)
- Stroke Volume/Index (SV/SVI)
- Systolic Pressure Variation (SPV)
- Stroke Volume Variation (SVV)
- Plethysmographic Waveform Variation (PWV)
- Inclusion criteria
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA (American Society of Anesthesiologists)class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
- Exclusion criteria
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
- Study course, measurements and analysis
- All study participants will get an explanation and sign on informed consent at least one day prior to the day of surgery
- All study participants will receive standard anesthesia care. All patients will anesthetized intravenously with Fentanyl 2-5 mcg/kg, Propofol 1-2 mg/kg and Rocuronium 0.6-1.0 mg/kg followed by endotracheal intubation. Positive pressure ventilation with tidal volume 8 mL/kg of ideal body weight and respiratory rate 8-12 bpm to achieve end-tidal carbon dioxide of 33-37 mmHg will be applied after intubation. Anesthesia will be maintained with inhalation of Isoflurane (end-expiratory concentration at least 1.2%) in air/O2 (FiO2=0.4). Intraoperative fluid management will include an initial bolus of crystalloid solution (lactated Ringer's solution) at a dose of 7 mL/kg. Arterial blood pressure will be measured continuously through a radial arterial catheter. Pulse oximetry photoplethysmography will be monitored by index finger probe on the same side. Cardiac output will monitored noninvasively by NICOM (Non-invasive cardiac output monitor) that calculates stroke volume variation (SVV) in addition to cardiac output/cardiac index and stroke volume/stroke index
- The study procedure will begin after induction of anesthesia, preparation of the patient for surgery and insertion of the pneumoperitoneum insufflation device. The study procedure will last for 10-15 minutes and will be finished before actual intraperitoneal surgical manipulation begins
- Waveforms will be recorded from the patient monitor and values of NICOM will be noted at baseline before surgical manipulation, at PnP pressure=0 mmHg before gas insufflation but after insertion of peritoneal needle, and after PnP pressure reaches 15 mmHg (routine value for laparoscopic surgery). If after reaching PnP pressure of 15 mmHg CO will decrease by more than 20%, the PnP pressure will be reduced to 10 mmHg and recording of waveforms will be repeated after two minutes
- Standard hemodynamic parameters (heart rate, systolic and diastolic BP) and waveform variables (SPV, PWV) will be measured and calculated offline according to the records
- Parameters measured by NICOM (CO, CI, SV, SVI, SVV) will be noted at baseline (PnP pressure=0 mmHg), after PnP pressure reached 15 mmHg and after PnP pressure decreased till 10 mmHg (if necessary)
- There will be no further follow up of the patients
- We anticipate that there will be a significant number of patients with a reduction of CO by 20% or more after establishment of PnP of 15 mm Hg. We will perform comparisons between waveforms at baseline between those who decrease CO and those who do not. If there will be significant difference in variables at baseline there will be justification to perform ROC analysis to evaluate sensitivity and specificity of these variables to predict decrease in CO. In patients who will have a decrease in CO after PnP of 15 mm Hg we will compare the same variables to those that will be reached at PnP of 10 mmHg. These comparisons can help to understand the mechanisms of CO decrease during PnP
- All of the analysis of the data will be performed after removing all identifying data
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumoperitoneum | Experimental | Procedure: PneumoperitoneumPatients undergoing laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- The patients ASA class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- Pneumoperitoneum by needle application only
- Normal sinus cardiac rhythm
Key exclusion criteria (4 listed)
- Patients that didn't sign informed consent
- Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
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 |
|---|---|---|
| PneumoperitoneumPneumoperitoneum 15 mmHg and 10 mmHg | Procedure or surgery | Pneumoperitoneum |
Primary outcome
Cardiac output/cardiac index
Time frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
Cardiac output/cardiac index will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
1 secondary outcome
Systolic pressure variation (SPV)/Pulse pressure variation (PPV)
Time frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Pizov Reuven, MD principal investigator
Carmel Medical Center
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 in people with Pneumoperitoneum and Heart Output Disorder, run by Carmel Medical Center at 1 site in Israel.
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 4 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 5 Aug 2015. 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 Israel. 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 Reuven Pizov, MD (97248250625, pizov_reuven@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output/cardiac index (time frame: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum). 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 Aug 2015.