Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01867814
Status:
UNKNOWN
Last Update Posted:
2015-08-05
First Post:
2013-05-27
Brief Title:
Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum
Sponsor:
Carmel Medical Center
Organization:
Carmel Medical Center
Study Overview
Official Title:
Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPV-PnP
Brief 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
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
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 OutputIndex COCI
Stroke VolumeIndex SVSVI
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 Anesthesiologistsclass 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 didnt 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 mcgkg Propofol 1-2 mgkg and Rocuronium 06-10 mgkg followed by endotracheal intubation Positive pressure ventilation with tidal volume 8 mLkg 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 12 in airO2 FiO204 Intraoperative fluid management will include an initial bolus of crystalloid solution lactated Ringers solution at a dose of 7 mLkg 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 outputcardiac index and stroke volumestroke 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 pressure0 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 pressure0 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
To evaluate hemodynamic changes caused by pneumoperitoneum applied for laparoscopic surgery
Endpoints
Blood Pressure Systolic Diastolic Mean SBP DBP MBP
Heart Rate HR
Cardiac OutputIndex COCI
Stroke VolumeIndex SVSVI
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 Anesthesiologistsclass 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 didnt 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 mcgkg Propofol 1-2 mgkg and Rocuronium 06-10 mgkg followed by endotracheal intubation Positive pressure ventilation with tidal volume 8 mLkg 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 12 in airO2 FiO204 Intraoperative fluid management will include an initial bolus of crystalloid solution lactated Ringers solution at a dose of 7 mLkg 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 outputcardiac index and stroke volumestroke 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 pressure0 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 pressure0 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None