Decision Support for Intraoperative Low Blood Pressure

Summary

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.

Conditions

• Hypotension

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

DEVICE

Anesthesia Information Management System (AIMS)

The anesthesia electronic record keeping system

DEVICE

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.

PROCEDURE

General anesthesia

Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.

DEVICE

Pager system

The mobile pager system through which alerts can be sent

PROCEDURE

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.

PROCEDURE

Non-cardiac surgery

Any surgical intervention that is not aimed at surgical correction of the heart

DRUG

Propofol

Anesthetic drug used to maintain general anesthesia

DRUG

Sevoflurane

Anesthetic drug used to maintain general anesthesia

DRUG

Desflurane

Anesthetic drug used to maintain general anesthesia

DRUG

Isoflurane

Anesthetic drug used to maintain general anesthesia

DRUG

Ephedrine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Phenylephrine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Norepinephrine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Epinephrine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Dobutamine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Dopamine

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Isoproterenol

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Milrinone

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Atropine

Cardiovascular drugs used to treat intraoperative hypotension

DRUG

Glycopyrrolate

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Vasopressin

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Terlipressin

Cardiovascular drug used to treat intraoperative hypotension

DRUG

Sodium Chloride 0.9%

Intravenous fluid used to treat intraoperative hypotension

DRUG

Ringer's lactate

Intravenous fluid used to treat intraoperative hypotension

DRUG

Hydroxyethyl starch solutions

Intravenous fluid used to treat intraoperative hypotension

DRUG

Fresh Frozen Plasma

Intravenous fluid used to treat intraoperative hypotension

DRUG

Packed Red Blood Cells

Intravenous fluid used to treat intraoperative hypotension

DRUG

Albumin solutions

Intravenous fluid used to treat intraoperative hypotension

DRUG

Plasma-Lyte

Intravenous fluid used to treat intraoperative hypotension

DRUG

Lidocaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Bupivacaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Levobupivacaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Ropivacaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Mepivacaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Tetracaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Prilocaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Procaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Chloroprocaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Benzocaine

Local anesthetic used for central neuraxial anesthesia.

DRUG

Articaine

Local anesthetic used for central neuraxial anesthesia.

Sponsors & Collaborators

• UMC Utrecht

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Jonathan P Wanderer, MD, MPhil · Vanderbilt University Medical Center, Department of Anesthesiology

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

60 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-05

Primary Completion

2017-12-31

Completion

2018-12-29

Countries

• United States

Study Locations