Study Results
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View full resultsBasic Information
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COMPLETED
NA
22435 participants
INTERVENTIONAL
2017-01-05
2018-12-29
Brief Summary
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Detailed Description
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A big challenge in blood pressure management is to know when a low blood pressure indeed results in low perfusion of organs. There is a large variation between patients in how susceptible they are to low blood pressure, as well as a difference between the organs in how easily they are damaged because of low perfusion. Elder patients, or patients with preexisting hypertension, heart problems or other cardiovascular diseases are more prone to a low blood pressure and are more likely to develop organ ischemia when there is a low blood pressure. The kidneys, the heart and the brain are the organs that are most at risk of organ damage. As one cannot measure the perfusion states of individual organs in individual patients, it is very difficult to know 'how low to go' with a patient's blood pressure.
Recent studies have used large datasets of patients to demonstrate that there is statistical association between low blood pressure during surgery and various types of organ injury. As patients are already treated for low blood pressure by anesthesia providers, this suggests that patients have low organ perfusion states despite the current treatment standards. A patient's blood pressure is not simply a dial that can be adjusted to a specific level. Finding the right level of interventions can be difficult in some patients. Consequently, lower blood pressures are common in anesthesia, even with the current standards of blood pressure management.
In this proposed study the investigators will implement two forms of decision support to assist anesthesia providers in blood pressure management. The decision support aims to educate anesthesia providers about the risks of low blood pressures in direct relation to the patients that they treat. One form of decision support will provide automated notifications through pagers and through the anesthesia information management system. These automated notifications pop up when the patient's blood pressure drops below a level that is associated with a risk of organ injury, and thus alerts the anesthesia provider of the blood pressure and its associated risk. The second form of decision support will send a postoperative email the day after the procedure when the patient has had a low blood pressure for particular duration. This email then provides feedback to the anesthesia provider by informing them of the increased risks of organ injury that are associated with that low blood pressure.
The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical Center (VUMC). The change in patient outcome will primarily be studied through the occurrence of acute kidney injury in the first days following the procedure at the VUMC. The change in blood pressure management (provider behavior) will be studied by observing the depth and duration of low pressures during anesthesia, and the number of interventions that have been used to treat the blood pressure. Patient outcome will be studied by comparison of a baseline phase - before the decision support is implemented and uses historic data- and the intervention phase - the period during which the intervention is active. Only routinely collected clinical data will be used for these analyses: no additional data collection is required.
As it is impossible to know which form of decision support will be the most effective, the first three months of the intervention period will be a 'nested cluster-randomized trial'. The anesthesia providers (not the patients) will be randomized to either the automated notifications or the feedback emails. After three months all anesthesia providers will receive both forms of decision support for the remainder of the intervention period. The reason why anesthesia providers are randomized only during the first three months is that cross-over or contamination between the two groups is expected. This contamination could make it impossible to study the effect of the decision support on patient outcome, as there will be no longer any difference between the study groups.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Hypotension decision support
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
Attending real-time decision support
Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.
In-room real-time decision support
Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.
Attending feedback emails
Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
In-room provider feedback emails
In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
Anesthesia Information Management System (AIMS)
The anesthesia electronic record keeping system
Perioperative Data Warehouse (PDW)
The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Pager system
The mobile pager system through which alerts can be sent
Central neuraxial anesthesia
Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
Non-cardiac surgery
Any surgical intervention that is not aimed at surgical correction of the heart
Propofol
Anesthetic drug used to maintain general anesthesia
Sevoflurane
Anesthetic drug used to maintain general anesthesia
Desflurane
Anesthetic drug used to maintain general anesthesia
Isoflurane
Anesthetic drug used to maintain general anesthesia
Ephedrine
Cardiovascular drug used to treat intraoperative hypotension
Phenylephrine
Cardiovascular drug used to treat intraoperative hypotension
Norepinephrine
Cardiovascular drug used to treat intraoperative hypotension
Epinephrine
Cardiovascular drug used to treat intraoperative hypotension
Dobutamine
Cardiovascular drug used to treat intraoperative hypotension
Dopamine
Cardiovascular drug used to treat intraoperative hypotension
Isoproterenol
Cardiovascular drug used to treat intraoperative hypotension
Milrinone
Cardiovascular drug used to treat intraoperative hypotension
Atropine
Cardiovascular drugs used to treat intraoperative hypotension
Glycopyrrolate
Cardiovascular drug used to treat intraoperative hypotension
Vasopressin
Cardiovascular drug used to treat intraoperative hypotension
Terlipressin
Cardiovascular drug used to treat intraoperative hypotension
Sodium Chloride 0.9%
Intravenous fluid used to treat intraoperative hypotension
Ringer's lactate
Intravenous fluid used to treat intraoperative hypotension
Hydroxyethyl starch solutions
Intravenous fluid used to treat intraoperative hypotension
Fresh Frozen Plasma
Intravenous fluid used to treat intraoperative hypotension
Packed Red Blood Cells
Intravenous fluid used to treat intraoperative hypotension
Albumin solutions
Intravenous fluid used to treat intraoperative hypotension
Plasma-Lyte
Intravenous fluid used to treat intraoperative hypotension
Lidocaine
Local anesthetic used for central neuraxial anesthesia.
Bupivacaine
Local anesthetic used for central neuraxial anesthesia.
Levobupivacaine
Local anesthetic used for central neuraxial anesthesia.
Ropivacaine
Local anesthetic used for central neuraxial anesthesia.
Mepivacaine
Local anesthetic used for central neuraxial anesthesia.
Tetracaine
Local anesthetic used for central neuraxial anesthesia.
Prilocaine
Local anesthetic used for central neuraxial anesthesia.
Procaine
Local anesthetic used for central neuraxial anesthesia.
Chloroprocaine
Local anesthetic used for central neuraxial anesthesia.
Benzocaine
Local anesthetic used for central neuraxial anesthesia.
Articaine
Local anesthetic used for central neuraxial anesthesia.
Usual care group
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Central neuraxial anesthesia
Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
Non-cardiac surgery
Any surgical intervention that is not aimed at surgical correction of the heart
Propofol
Anesthetic drug used to maintain general anesthesia
Sevoflurane
Anesthetic drug used to maintain general anesthesia
Desflurane
Anesthetic drug used to maintain general anesthesia
Isoflurane
Anesthetic drug used to maintain general anesthesia
Ephedrine
Cardiovascular drug used to treat intraoperative hypotension
Phenylephrine
Cardiovascular drug used to treat intraoperative hypotension
Norepinephrine
Cardiovascular drug used to treat intraoperative hypotension
Epinephrine
Cardiovascular drug used to treat intraoperative hypotension
Dobutamine
Cardiovascular drug used to treat intraoperative hypotension
Dopamine
Cardiovascular drug used to treat intraoperative hypotension
Isoproterenol
Cardiovascular drug used to treat intraoperative hypotension
Milrinone
Cardiovascular drug used to treat intraoperative hypotension
Atropine
Cardiovascular drugs used to treat intraoperative hypotension
Glycopyrrolate
Cardiovascular drug used to treat intraoperative hypotension
Vasopressin
Cardiovascular drug used to treat intraoperative hypotension
Terlipressin
Cardiovascular drug used to treat intraoperative hypotension
Sodium Chloride 0.9%
Intravenous fluid used to treat intraoperative hypotension
Ringer's lactate
Intravenous fluid used to treat intraoperative hypotension
Hydroxyethyl starch solutions
Intravenous fluid used to treat intraoperative hypotension
Fresh Frozen Plasma
Intravenous fluid used to treat intraoperative hypotension
Packed Red Blood Cells
Intravenous fluid used to treat intraoperative hypotension
Albumin solutions
Intravenous fluid used to treat intraoperative hypotension
Plasma-Lyte
Intravenous fluid used to treat intraoperative hypotension
Lidocaine
Local anesthetic used for central neuraxial anesthesia.
Bupivacaine
Local anesthetic used for central neuraxial anesthesia.
Levobupivacaine
Local anesthetic used for central neuraxial anesthesia.
Ropivacaine
Local anesthetic used for central neuraxial anesthesia.
Mepivacaine
Local anesthetic used for central neuraxial anesthesia.
Tetracaine
Local anesthetic used for central neuraxial anesthesia.
Prilocaine
Local anesthetic used for central neuraxial anesthesia.
Procaine
Local anesthetic used for central neuraxial anesthesia.
Chloroprocaine
Local anesthetic used for central neuraxial anesthesia.
Benzocaine
Local anesthetic used for central neuraxial anesthesia.
Articaine
Local anesthetic used for central neuraxial anesthesia.
Interventions
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Attending real-time decision support
Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.
In-room real-time decision support
Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.
Attending feedback emails
Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
In-room provider feedback emails
In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
Anesthesia Information Management System (AIMS)
The anesthesia electronic record keeping system
Perioperative Data Warehouse (PDW)
The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Pager system
The mobile pager system through which alerts can be sent
Central neuraxial anesthesia
Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
Non-cardiac surgery
Any surgical intervention that is not aimed at surgical correction of the heart
Propofol
Anesthetic drug used to maintain general anesthesia
Sevoflurane
Anesthetic drug used to maintain general anesthesia
Desflurane
Anesthetic drug used to maintain general anesthesia
Isoflurane
Anesthetic drug used to maintain general anesthesia
Ephedrine
Cardiovascular drug used to treat intraoperative hypotension
Phenylephrine
Cardiovascular drug used to treat intraoperative hypotension
Norepinephrine
Cardiovascular drug used to treat intraoperative hypotension
Epinephrine
Cardiovascular drug used to treat intraoperative hypotension
Dobutamine
Cardiovascular drug used to treat intraoperative hypotension
Dopamine
Cardiovascular drug used to treat intraoperative hypotension
Isoproterenol
Cardiovascular drug used to treat intraoperative hypotension
Milrinone
Cardiovascular drug used to treat intraoperative hypotension
Atropine
Cardiovascular drugs used to treat intraoperative hypotension
Glycopyrrolate
Cardiovascular drug used to treat intraoperative hypotension
Vasopressin
Cardiovascular drug used to treat intraoperative hypotension
Terlipressin
Cardiovascular drug used to treat intraoperative hypotension
Sodium Chloride 0.9%
Intravenous fluid used to treat intraoperative hypotension
Ringer's lactate
Intravenous fluid used to treat intraoperative hypotension
Hydroxyethyl starch solutions
Intravenous fluid used to treat intraoperative hypotension
Fresh Frozen Plasma
Intravenous fluid used to treat intraoperative hypotension
Packed Red Blood Cells
Intravenous fluid used to treat intraoperative hypotension
Albumin solutions
Intravenous fluid used to treat intraoperative hypotension
Plasma-Lyte
Intravenous fluid used to treat intraoperative hypotension
Lidocaine
Local anesthetic used for central neuraxial anesthesia.
Bupivacaine
Local anesthetic used for central neuraxial anesthesia.
Levobupivacaine
Local anesthetic used for central neuraxial anesthesia.
Ropivacaine
Local anesthetic used for central neuraxial anesthesia.
Mepivacaine
Local anesthetic used for central neuraxial anesthesia.
Tetracaine
Local anesthetic used for central neuraxial anesthesia.
Prilocaine
Local anesthetic used for central neuraxial anesthesia.
Procaine
Local anesthetic used for central neuraxial anesthesia.
Chloroprocaine
Local anesthetic used for central neuraxial anesthesia.
Benzocaine
Local anesthetic used for central neuraxial anesthesia.
Articaine
Local anesthetic used for central neuraxial anesthesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inpatients
* Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia
Exclusion Criteria
* The following surgical procedures: renal surgery, cardiac surgery, organ transplantation, ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures.
* small non-invasive or minimally-invasive procedures will also be excluded, operationalized as excluding procedures with a surgical time of less than twenty minutes.
60 Years
100 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Jonathan Wanderer
Medical Director of Procedure Preparation Center
Principal Investigators
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Jonathan P Wanderer, MD, MPhil
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center, Department of Anesthesiology
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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160131
Identifier Type: -
Identifier Source: org_study_id
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