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The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery
The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Basic intraoperative hemodynamic objectives |
|
| Goal directed therapy | Experimental | Target value is a cardiac index equal or superior to 2.2 l/min/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Procedure | Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) | To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2. | During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Perfusion Marker: Lactate | To compare lactate in the first 24 hours in both groups | Within 24 hours after lung surgery |
| Tissue Perfusion Marker: SvcO2 | To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Bertomeu, MD-PhD | Andaluz Health Service | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Virgen del RocÃo | Seville | 41013 | Spain |
Yes. Anonymized data for individual patient data is planned to be shared with all participants within 6 months of data completion
6 months after the completion of data analysis
colaborators in the investigation will be open to the whole data base and analysis performed
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31 patients signed informed consent, but there was a pre-randomization exclusion (a patient was selected and signed informed consent) because surgeons decided to carry out a less aggressive surgery from the start (atypical lung resection instead of lobectomy). That happened in only one case.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). |
| FG001 | Goal Directed Therapy | Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). |
| BG001 | Goal Directed Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) | To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2. | Posted | Median | Inter-Quartile Range | percentage of time | During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Basic intraoperative hemodynamic objectives Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
This is a pilot study and the clinician (anesthesiologist) who performed the anesthetic procedure had to know the assignment of the arm. The intervention was limited to the intraoperative period. Postoperative morbidity and mortality surveillance was limited to one month. The study, therefore, was not designed to have sufficient power to detect significant differences in major postoperative complications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alejandro DomÃnguez-Blanco | Hospital Universitario Virgen del RocÃo, Servicio Andaluz de Salud | 0034660762856 | aledguez@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2017 | Jun 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000074388 | Early Goal-Directed Therapy |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Goal directed therapy | Procedure | The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. |
|
|
| Within 24 hours after lung surgery |
| Oxygenation Marker: PaO2/FiO2 Ratio | To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups | Within 24 hours after lung surgery |
| Fluid Balance | To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups | After 24 hours of finalization of lung surgery |
| Observation of Acute Kidney Injury (AKI) | To compare the Number of Participants with Acute Kidney Injury in both groups | After 72 hours of finalization of lung surgery |
| Observation of Acute Respiratory Distress Syndrome (ARDS) | To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups | Within 30 days after lung surgery |
| Duration of Hospital Stay | To compare hospital stay in both groups | Within 30 days after lung surgery |
| Mortality | To compare the mortality rate in both groups | Within 30 days after lung surgery |
Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Smoking history | Count of Participants | Participants |
|
| Smoking exposure | Median | Standard Deviation | pack-years |
|
| ASA Physical Status Classification System | The ASA Physical Status Classification System has been in use for over 60 years. The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. It can be helpful in predicting perioperative risks.
ASA III-IV-V may have worse outcomes than I or II | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Ischemic heart disease | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| COPD grade GOLD is equal or superior to 2 | COPD (chronic obstructive pulmonary disease) stages and the GOLD (Global Initiative for Obstructive Lung Disease) criteria:
COPD grade II or above II may have worse outcomes than patients grade I or without that desease | Count of Participants | Participants |
|
| cerebrovascular disease | Count of Participants | Participants |
|
Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. |
|
|
|
| Secondary | Tissue Perfusion Marker: Lactate | To compare lactate in the first 24 hours in both groups | Posted | Median | Inter-Quartile Range | mmol/L | Within 24 hours after lung surgery |
|
|
|
|
| Secondary | Tissue Perfusion Marker: SvcO2 | To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups | Posted | Mean | Standard Deviation | percentage of saturation | Within 24 hours after lung surgery |
|
|
|
|
| Secondary | Oxygenation Marker: PaO2/FiO2 Ratio | To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups | Posted | Median | Inter-Quartile Range | mm Hg | Within 24 hours after lung surgery |
|
|
|
|
| Secondary | Fluid Balance | To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups | Posted | Mean | Standard Deviation | milliliters | After 24 hours of finalization of lung surgery |
|
|
|
|
| Secondary | Observation of Acute Kidney Injury (AKI) | To compare the Number of Participants with Acute Kidney Injury in both groups | Posted | Count of Participants | Participants | After 72 hours of finalization of lung surgery |
|
|
|
|
| Secondary | Observation of Acute Respiratory Distress Syndrome (ARDS) | To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups | Posted | Count of Participants | Participants | Within 30 days after lung surgery |
|
|
|
| Secondary | Duration of Hospital Stay | To compare hospital stay in both groups | Posted | Median | Inter-Quartile Range | days | Within 30 days after lung surgery |
|
|
|
|
| Secondary | Mortality | To compare the mortality rate in both groups | Posted | Count of Participants | Participants | Within 30 days after lung surgery |
|
|
|
|
| 1 |
| 15 |
| 3 |
| 15 |
| 12 |
| 15 |
| EG001 | Goal Directed Therapy | Target value is a cardiac index equal or superior to 2.2 l/min/m2. Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. | 0 | 15 | 4 | 15 | 14 | 15 |
| Thoracic Pain | Cardiac disorders | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial Fibrillation Paroxysmal | Cardiac disorders | Systematic Assessment |
|
| Severe Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Exanthema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Postoperative Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Surgical Site Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arterial Hypotension | Cardiac disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Mild-Moderate Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D003422 | Critical Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |