Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01788293
Status:
TERMINATED
Last Update Posted:
2021-02-10
First Post:
2013-02-06
Brief Title:
Fluid Management Based on Pleth Variability Index PVI Monitoring During High-risk Surgery
Sponsor:
Hospital Regional de Presidente Prudente
Organization:
Hospital Regional de Presidente Prudente
Study Overview
Official Title:
Fluid Management Based on Pleth Variability Index PVI Monitoring During High-risk Surgery
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Problem with recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oximetry monitoring is common practice in patients undergoing anesthesia PVI continuous evaluation may be a possibility of agility and ease of obtaining accurate information about the state of cardiovascular responsiveness to volume expansion
This prospective and randomized study will try to demonstrate that the assessment of PVI is a simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring technologies Such a simple approach has therefore the potential for widespread application as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery monitoring technologies in many institutions as well as in many countries
This prospective and randomized study will try to demonstrate that the assessment of PVI is a simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring technologies Such a simple approach has therefore the potential for widespread application as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery monitoring technologies in many institutions as well as in many countries
Detailed Description:
Introduction
Several studies have shown that cardiac output optimization improve postoperative outcome and to decrease the cost of surgery Boyd et al 1993 Gan et al 2002 Kern Shoemaker 2002 Pearse et al 2005 Poeze et al 2005 Sinclair et al 1997 Wakeling et al 2005
Respiratory variations in the arterial pulse pressure and in the pulse oximetry plethysmographic waveform amplitude have been extensively studied in mechanically ventilated patients and have been demonstrated to be sensitive to changes in ventricular preload as well as reliable predictors of fluid responsiveness in adults Cannesson et al 2007 Cannesson et al 2008 Natalini et al 2006 Solus-Biguenet et al 2006 Zimmermann et al 2010
A few studies have evaluated the impact of a pulse-pressure-variations-guided fluid management on perioperative outcome Buettner et al 2008 Fukui et al 2007 Fukui et al 2009 Kobayashi et al 2008 Lopes et al 2007 Mayer et al 2009 Oubaha Poelaert 2009 Sakamoto et al 2009 However results from these studies are not conclusive and further studies are required to better explore this topic Cannesson 2010
Pulse oximeters are part of the routine monitoring during anesthesia and in the intensive care unit Dorlas Nijboer 1985 The main interest of the pulse oxymeter is to display arterial oxygenation continuously Pleth variability index PVI is an automatic measure of the dynamic change in perfusion index PI that occurs during a complete respiratory cycle PVI is provided currently by one pulse oximeter manufacturer Masimo Radical 7 Masimo Corporation Irvine CA USA The PVI calculation measures changes in PI over a time interval sufficient to include one or more complete respiratory cycles as and is displayed continuously Cannesson et al 2008 Zimmermann et al 2010 PVI quantifies the variability in plethysmograph waveform due to respiration and is thought to be a surrogate measure of intravascular volume Cannesson et al 2008 Zimmermann et al 2010 Cannesson et al reported that a PVI value above 14 predicted fluid responsiveness Cannesson et al 2008 Therefore the clinical and intra-operative goal of maximizing stroke volume by volume loading can be achieved by reducing PVI below 14 Cannesson et al 2008 Zimmermann et al 2010 Forget et al 2010 demonstrated that PVI based goal-directed fluid management reduced the volume of intraoperative fluid infused and reduced intraoperative and postoperative lactate levels However to our knowledge there is no study that evaluate the impact of PVI guided fluid management on perioperative outcome
Materials and Methods
Patients This procol has been approved by the local Ethics Committee Hospital Regional de Presidente Prudente Presidente Prudente São Paulo Brazil The written informed consent will be obtained from each patient Adults patients underwent high-risk surgery will be selected and randomized to either a control group group C or an intervention group group I
Patients will be selected according to a pre-operative decision by the surgeon and the intensivist that post-operative care would be undertaken in the ICU because of co-morbidities orand the surgical procedure Patients 18 years with cardiac arrhythmias with a body mass index 40 and those undergoing surgery with an open thorax neurosurgery or emergency surgery will be excluded
Intraoperative monitoring
On the day of surgery they will receive their respective medication in association with anesthetic premedication Immediately after the arrival in the operating room heart rate pulse oximetry blood pressure and capnography will be monitored with a multiparameter bedside monitor DX 2023 Dixtal São Paulo Brazil A 20-G catheter line Smith Medical International Lancashire Uk will be inserted in the radial artery for continuous arterial pressure measurement and recording The radial catheter will be connected to a Dixtal DX 2023 monitor São Paulo Brazil
The patients will be anesthetized with loading doses of propofol 2 mgkg sufentanil 02 - 03 µgkg and atracurium 06 mgkg Anesthesia will be maintained by infusion of the same products After induction of anesthesia patients underwent tracheal intubation Artificial ventilation will be provided by a Fabius plus ventilator Dräger Lübeck Germany respiration rate 12 strokesmin tidal volume 8 to 10 mlkg
Each respiratory cycle will be identified from the capnogram systolic and diastolic arterial pressures will be measured on a beat-to-beat basis In patients of intervention group PVI values will be determined over each respiratory cycle Masimo Radical 7 Masimo Corporation Irvine CA USA
Protocol Randomization will be done pre-operatively using sealed envelopes During the surgical procedure patients will be managed according to our institutions standard of care Group C will receive per-operative fluid at the discretion of the anesthetist whereas group I will receive additional hydroxyethylstarch 6 HES bolus in order to minimize and maintain PVI below 14 This PVI cut-off value was chosen according to previous reports Cannesson et al 2008 Zimmermann et al 2010
During the postoperative period both groups were managed by intensivists in the ICU and clinicians in the wards not involved in the intraoperative management or in data collection These individuals were not informed of patient allocation
Data collection
Over the study period all data will be collected prospectively and patients will be followed up until hospital discharge Pre and intraoperative data collection will be undertaken by one of the investigators whereas post-operative data collection will be undertaken by another who was not aware of the allocation group Before surgery sex age weight height history of renal failure requiring dialysis or not cirrhosis chronic obstructive pulmonary disease hypertension peripheral vascular disease coronary artery disease other cardiac disease diabetes mellitus and cerebrovascular disease will be recorded The body mass index will be calculated according to the standard formula BMI weightheight2 Serum creatinine prothrombin time hemoglobin and platelets will be obtained from routine pre-operative biological tests During the surgical procedure tidal volume ventilatory frequency infused volume of crystalloid solutions HES and blood products will be recorded Heart rate mean arterial pressure percutaneous arterial oxygen saturation and hemoglobin will be collected both at the beginning and the end of the surgical procedure The duration of surgery will be also recorded After the surgical procedure the following parameters will be collected both at ICU admission and 24h later mean arterial pressure heart rate percutaneous arterial oxygen saturation During the 24h following ICU admission venous lactate will be measured every 6h and the mean lactate value will be calculated over the first 24h ICU period The need for continuous vasoactive dobutamine orand norepinephrine support will be recorded
Postoperative ICU infections pneumonia abdominal urinary tract line related sepsis and wound infections respiratory complications pulmonary embolism acute lung injury and respiratory support 24h exclusive of acute lung injury cardiovascular complications arrhythmia hypotension acute pulmonary edema acute myocardial infarction stroke and cardiac arrest exclusive of fatal outcome abdominal complications clostridium difficile diarrhoea acute bowel obstruction upper gastro-intestinal bleed and anastomotic leak hematologic complications platelet count 100000µl or prothrombin time 15 times control and renal complications urine output 500 mlday or serum creatinine 170 µmolL or dialysis for acute renal failure were collected according to criteria previously used by other investigators Bennett-Guerrero et al 1999 Gan et al 2002 Lopes et al 2007 Pearse et al 2005
Statistical analysis
Data will be analyzed comparing patients in group C with those in group I on an intention-to treat basis The primary outcome measure will be the duration of postoperative hospital stay On the basis of our own hospital registry the mean duration of postoperative hospital stay in group C is a priori estimated at 15 7 days median median absolute deviation According to previous publications we postulated that the mean duration of postoperative hospital stay in group I could be 35 lower Lopes et al 2007 Mythen Webb 1995 Sinclair et al 1997 A sample size of 35 patients in each group was calculated for a 005 difference two sided with a power of 80 Schulz Grimes 2005 An intermediate analysis after the enrolment of the first 35 patients was planed in order to readjust the population sample size if necessary Secondary outcome measures were the number of post-operative complications per patient as well as the duration of mechanical ventilation and ICU stay Results are expressed as median median absolute deviation The median absolute deviation is a variation of the average absolute deviation that is even less affected by outlying values because these values have less influence on the calculation of the median than they do on the mean In general for data with extreme values the median absolute deviation or interquartile range can provide a more stable estimate or variability than the standard deviation
The Mann-Whitney U test was used to compare between groups patient characteristics as well as the duration of mechanical ventilation ICU stay and hospital stay In group I the effects of volume expansion with HES administration in PVI will be assessed using a nonparametric Wilcoxon rank sum test within each group of patients A Fisher exact test was performed to compare nominal data Linear correlations were tested using the Spearman rank method A p-value lower than a 005 chosen level is regarded as statistically significant All statistical analyses are performed using the StatView TM software for Windows version 457 Abacus Concepts Inc Berkeley CA USA
Several studies have shown that cardiac output optimization improve postoperative outcome and to decrease the cost of surgery Boyd et al 1993 Gan et al 2002 Kern Shoemaker 2002 Pearse et al 2005 Poeze et al 2005 Sinclair et al 1997 Wakeling et al 2005
Respiratory variations in the arterial pulse pressure and in the pulse oximetry plethysmographic waveform amplitude have been extensively studied in mechanically ventilated patients and have been demonstrated to be sensitive to changes in ventricular preload as well as reliable predictors of fluid responsiveness in adults Cannesson et al 2007 Cannesson et al 2008 Natalini et al 2006 Solus-Biguenet et al 2006 Zimmermann et al 2010
A few studies have evaluated the impact of a pulse-pressure-variations-guided fluid management on perioperative outcome Buettner et al 2008 Fukui et al 2007 Fukui et al 2009 Kobayashi et al 2008 Lopes et al 2007 Mayer et al 2009 Oubaha Poelaert 2009 Sakamoto et al 2009 However results from these studies are not conclusive and further studies are required to better explore this topic Cannesson 2010
Pulse oximeters are part of the routine monitoring during anesthesia and in the intensive care unit Dorlas Nijboer 1985 The main interest of the pulse oxymeter is to display arterial oxygenation continuously Pleth variability index PVI is an automatic measure of the dynamic change in perfusion index PI that occurs during a complete respiratory cycle PVI is provided currently by one pulse oximeter manufacturer Masimo Radical 7 Masimo Corporation Irvine CA USA The PVI calculation measures changes in PI over a time interval sufficient to include one or more complete respiratory cycles as and is displayed continuously Cannesson et al 2008 Zimmermann et al 2010 PVI quantifies the variability in plethysmograph waveform due to respiration and is thought to be a surrogate measure of intravascular volume Cannesson et al 2008 Zimmermann et al 2010 Cannesson et al reported that a PVI value above 14 predicted fluid responsiveness Cannesson et al 2008 Therefore the clinical and intra-operative goal of maximizing stroke volume by volume loading can be achieved by reducing PVI below 14 Cannesson et al 2008 Zimmermann et al 2010 Forget et al 2010 demonstrated that PVI based goal-directed fluid management reduced the volume of intraoperative fluid infused and reduced intraoperative and postoperative lactate levels However to our knowledge there is no study that evaluate the impact of PVI guided fluid management on perioperative outcome
Materials and Methods
Patients This procol has been approved by the local Ethics Committee Hospital Regional de Presidente Prudente Presidente Prudente São Paulo Brazil The written informed consent will be obtained from each patient Adults patients underwent high-risk surgery will be selected and randomized to either a control group group C or an intervention group group I
Patients will be selected according to a pre-operative decision by the surgeon and the intensivist that post-operative care would be undertaken in the ICU because of co-morbidities orand the surgical procedure Patients 18 years with cardiac arrhythmias with a body mass index 40 and those undergoing surgery with an open thorax neurosurgery or emergency surgery will be excluded
Intraoperative monitoring
On the day of surgery they will receive their respective medication in association with anesthetic premedication Immediately after the arrival in the operating room heart rate pulse oximetry blood pressure and capnography will be monitored with a multiparameter bedside monitor DX 2023 Dixtal São Paulo Brazil A 20-G catheter line Smith Medical International Lancashire Uk will be inserted in the radial artery for continuous arterial pressure measurement and recording The radial catheter will be connected to a Dixtal DX 2023 monitor São Paulo Brazil
The patients will be anesthetized with loading doses of propofol 2 mgkg sufentanil 02 - 03 µgkg and atracurium 06 mgkg Anesthesia will be maintained by infusion of the same products After induction of anesthesia patients underwent tracheal intubation Artificial ventilation will be provided by a Fabius plus ventilator Dräger Lübeck Germany respiration rate 12 strokesmin tidal volume 8 to 10 mlkg
Each respiratory cycle will be identified from the capnogram systolic and diastolic arterial pressures will be measured on a beat-to-beat basis In patients of intervention group PVI values will be determined over each respiratory cycle Masimo Radical 7 Masimo Corporation Irvine CA USA
Protocol Randomization will be done pre-operatively using sealed envelopes During the surgical procedure patients will be managed according to our institutions standard of care Group C will receive per-operative fluid at the discretion of the anesthetist whereas group I will receive additional hydroxyethylstarch 6 HES bolus in order to minimize and maintain PVI below 14 This PVI cut-off value was chosen according to previous reports Cannesson et al 2008 Zimmermann et al 2010
During the postoperative period both groups were managed by intensivists in the ICU and clinicians in the wards not involved in the intraoperative management or in data collection These individuals were not informed of patient allocation
Data collection
Over the study period all data will be collected prospectively and patients will be followed up until hospital discharge Pre and intraoperative data collection will be undertaken by one of the investigators whereas post-operative data collection will be undertaken by another who was not aware of the allocation group Before surgery sex age weight height history of renal failure requiring dialysis or not cirrhosis chronic obstructive pulmonary disease hypertension peripheral vascular disease coronary artery disease other cardiac disease diabetes mellitus and cerebrovascular disease will be recorded The body mass index will be calculated according to the standard formula BMI weightheight2 Serum creatinine prothrombin time hemoglobin and platelets will be obtained from routine pre-operative biological tests During the surgical procedure tidal volume ventilatory frequency infused volume of crystalloid solutions HES and blood products will be recorded Heart rate mean arterial pressure percutaneous arterial oxygen saturation and hemoglobin will be collected both at the beginning and the end of the surgical procedure The duration of surgery will be also recorded After the surgical procedure the following parameters will be collected both at ICU admission and 24h later mean arterial pressure heart rate percutaneous arterial oxygen saturation During the 24h following ICU admission venous lactate will be measured every 6h and the mean lactate value will be calculated over the first 24h ICU period The need for continuous vasoactive dobutamine orand norepinephrine support will be recorded
Postoperative ICU infections pneumonia abdominal urinary tract line related sepsis and wound infections respiratory complications pulmonary embolism acute lung injury and respiratory support 24h exclusive of acute lung injury cardiovascular complications arrhythmia hypotension acute pulmonary edema acute myocardial infarction stroke and cardiac arrest exclusive of fatal outcome abdominal complications clostridium difficile diarrhoea acute bowel obstruction upper gastro-intestinal bleed and anastomotic leak hematologic complications platelet count 100000µl or prothrombin time 15 times control and renal complications urine output 500 mlday or serum creatinine 170 µmolL or dialysis for acute renal failure were collected according to criteria previously used by other investigators Bennett-Guerrero et al 1999 Gan et al 2002 Lopes et al 2007 Pearse et al 2005
Statistical analysis
Data will be analyzed comparing patients in group C with those in group I on an intention-to treat basis The primary outcome measure will be the duration of postoperative hospital stay On the basis of our own hospital registry the mean duration of postoperative hospital stay in group C is a priori estimated at 15 7 days median median absolute deviation According to previous publications we postulated that the mean duration of postoperative hospital stay in group I could be 35 lower Lopes et al 2007 Mythen Webb 1995 Sinclair et al 1997 A sample size of 35 patients in each group was calculated for a 005 difference two sided with a power of 80 Schulz Grimes 2005 An intermediate analysis after the enrolment of the first 35 patients was planed in order to readjust the population sample size if necessary Secondary outcome measures were the number of post-operative complications per patient as well as the duration of mechanical ventilation and ICU stay Results are expressed as median median absolute deviation The median absolute deviation is a variation of the average absolute deviation that is even less affected by outlying values because these values have less influence on the calculation of the median than they do on the mean In general for data with extreme values the median absolute deviation or interquartile range can provide a more stable estimate or variability than the standard deviation
The Mann-Whitney U test was used to compare between groups patient characteristics as well as the duration of mechanical ventilation ICU stay and hospital stay In group I the effects of volume expansion with HES administration in PVI will be assessed using a nonparametric Wilcoxon rank sum test within each group of patients A Fisher exact test was performed to compare nominal data Linear correlations were tested using the Spearman rank method A p-value lower than a 005 chosen level is regarded as statistically significant All statistical analyses are performed using the StatView TM software for Windows version 457 Abacus Concepts Inc Berkeley CA USA
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