Decision Support for Intraoperative Low Blood Pressure

Vanderbilt University Medical Center

Status: Completed

Conditions: Hypotension

Treatments: Device: Perioperative Data Warehouse (PDW); Drug: Sodium Chloride 0.9%; Drug: Prilocaine; Procedure: Attending real-time decision support; Procedure: Attending feedback emails; Drug: Glycopyrrolate; Drug: Procaine; Drug: Benzocaine; Drug: Hydroxyethyl starch solutions; Drug: Mepivacaine; Procedure: Central neuraxial anesthesia; Drug: Sevoflurane; Drug: Chloroprocaine; Drug: Phenylephrine; Drug: Atropine; Drug: Ropivacaine; Procedure: Non-cardiac surgery; Drug: Packed Red Blood Cells; Device: Anesthesia Information Management System (AIMS); Drug: Milrinone; Drug: Ringer's lactate; Drug: Isoproterenol; Drug: Ephedrine; Drug: Fresh Frozen Plasma; Procedure: In-room provider feedback emails; Drug: Lidocaine; Drug: Albumin solutions; Drug: Norepinephrine; Drug: Levobupivacaine; Drug: Dopamine; Drug: Terlipressin; Drug: Vasopressin; Drug: Desflurane; Drug: Articaine; Device: Pager system; Drug: Tetracaine; Procedure: General anesthesia; Drug: Bupivacaine; Procedure: In-room real-time decision support; Drug: Epinephrine; Drug: Isoflurane; Drug: Dobutamine; Drug: Propofol; Drug: Plasma-Lyte

Study type: Interventional

Funder types: Other

Identifiers

NCT02726620

160131

Details and patient eligibility

About

The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury.

Full description

Blood pressure management is an important part of anesthesia. Many factors contribute to a change in blood pressure during a surgical procedure, such as blood loss, manipulation by surgeons, and there are several mechanisms through which anesthesia itself changes blood pressure. Although a high blood pressure also occurs during anesthesia, most of these factors lower a patient's blood pressure. When a patient's blood pressure becomes too low, the internal organs become at risk of receiving not enough blood (low perfusion or hypoperfusion). This low perfusion state can result in organ damage (ischemia) because of an insufficient supply of oxygen and glucose. Hence the important task of anesthesia providers to maintain the blood pressure of patients, using a wide range of drugs and other interventions.

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.

Enrollment: 22,435 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 years and older
• Inpatients
• Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia

Exclusion criteria

• Pre-existing end-stage renal disease: operationalized as a preoperative need for dialysis
• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22,435 participants in 2 patient groups

Hypotension decision support

Experimental group

Description:

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.

Treatment:

Drug: Fresh Frozen Plasma

Drug: Ephedrine

Drug: Isoproterenol

Drug: Packed Red Blood Cells

Procedure: Attending feedback emails

Drug: Prilocaine

Drug: Ropivacaine

Procedure: Non-cardiac surgery

Procedure: Attending real-time decision support

Device: Perioperative Data Warehouse (PDW)

Drug: Ringer's lactate

Drug: Atropine

Device: Anesthesia Information Management System (AIMS)

Procedure: In-room provider feedback emails

Drug: Chloroprocaine

Drug: Glycopyrrolate

Drug: Lidocaine

Drug: Plasma-Lyte

Drug: Sevoflurane

Drug: Dobutamine

Drug: Levobupivacaine

Drug: Mepivacaine

Procedure: General anesthesia

Drug: Procaine

Drug: Terlipressin

Drug: Benzocaine

Drug: Albumin solutions

Drug: Sodium Chloride 0.9%

Drug: Articaine

Drug: Bupivacaine

Drug: Tetracaine

Device: Pager system

Drug: Epinephrine

Drug: Norepinephrine

Drug: Hydroxyethyl starch solutions

Drug: Propofol

Procedure: Central neuraxial anesthesia

Procedure: In-room real-time decision support

Drug: Milrinone

Drug: Isoflurane

Drug: Vasopressin

Drug: Desflurane

Drug: Dopamine

Drug: Phenylephrine

Usual care group

Active Comparator group

Description:

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).

Treatment:

Drug: Fresh Frozen Plasma

Drug: Ephedrine

Drug: Isoproterenol

Drug: Packed Red Blood Cells

Drug: Prilocaine

Drug: Ropivacaine

Procedure: Non-cardiac surgery

Drug: Ringer's lactate

Drug: Atropine

Drug: Chloroprocaine

Drug: Glycopyrrolate

Drug: Lidocaine

Drug: Plasma-Lyte

Drug: Sevoflurane

Drug: Dobutamine

Drug: Levobupivacaine

Drug: Mepivacaine

Procedure: General anesthesia

Drug: Procaine

Drug: Terlipressin

Drug: Benzocaine

Drug: Albumin solutions

Drug: Sodium Chloride 0.9%

Drug: Articaine

Drug: Bupivacaine

Drug: Tetracaine

Drug: Epinephrine

Drug: Norepinephrine

Drug: Hydroxyethyl starch solutions

Drug: Propofol

Procedure: Central neuraxial anesthesia

Drug: Milrinone

Drug: Isoflurane

Drug: Vasopressin

Drug: Desflurane

Drug: Dopamine

Drug: Phenylephrine