Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | March 2013 |
| Contact: | Donald M Mathews, M.D. |
| Email: | donald.mathews@vtmednet.org |
| Phone: | 802-847-2415 |
The purpose of this study is to determine whether the Halo Index has utility in detecting
the difference between normal and non-normal recovery of patients in the first few hours
immediately following major inpatient surgery. A small but significant percentage of
patients who undergo major surgery will experience a major life-threatening complication in
the first 30 days following surgery.
The chance of developing one or more of these complications increases with the size of the
surgery and with the severity of the patient's preexisting medical problems. It is unknown
whether fluctuations in a patient's vital signs and other measures of bodily function that
occur early in the recovery period are associated with postoperative complications. If this
is so, it may be possible to predict who is at increased risk for complications based on
monitoring during the early recovery period.
This study will make use of the Halo Index, a compilation of measures of patient functions
collected by non-invasive monitoring devices. In addition to heart rate, blood pressure,
temperature, and breathing rate, these include measures of dissolved oxygen in the blood,
the amount of hemoglobin in the blood, and other parameters.
Patients will have two additional non-invasive monitors attached during their stay in the
hospital post-anesthesia care unit (PACU). After the patient has been discharged from the
hospital, their medical record will be reviewed at two time points: The first will be soon
after discharge. Normal recovery patients will be defined as those who require only IV
fluids, pain medications and anti-emetic medications. Non-normal recovery will include
those who require transfusions of blood products, airway interventions such as a breathing
tube, blood pressure medications, or heart rhythm medications. The second chart review will
occur 30 days after surgery. In this review, the presence or absence of the following events
will be ascertained: rapid response team calls, admission to the intensive care unit,
infection, pneumonia, the need for transfusion of 5 or more units of blood within a
three-day period, septic shock, the need for ventilation with a breathing tube, blood clot
in the lung, kidney failure, coma, stroke, heart attack, and death.
the difference between normal and non-normal recovery of patients in the first few hours
immediately following major inpatient surgery. A small but significant percentage of
patients who undergo major surgery will experience a major life-threatening complication in
the first 30 days following surgery.
The chance of developing one or more of these complications increases with the size of the
surgery and with the severity of the patient's preexisting medical problems. It is unknown
whether fluctuations in a patient's vital signs and other measures of bodily function that
occur early in the recovery period are associated with postoperative complications. If this
is so, it may be possible to predict who is at increased risk for complications based on
monitoring during the early recovery period.
This study will make use of the Halo Index, a compilation of measures of patient functions
collected by non-invasive monitoring devices. In addition to heart rate, blood pressure,
temperature, and breathing rate, these include measures of dissolved oxygen in the blood,
the amount of hemoglobin in the blood, and other parameters.
Patients will have two additional non-invasive monitors attached during their stay in the
hospital post-anesthesia care unit (PACU). After the patient has been discharged from the
hospital, their medical record will be reviewed at two time points: The first will be soon
after discharge. Normal recovery patients will be defined as those who require only IV
fluids, pain medications and anti-emetic medications. Non-normal recovery will include
those who require transfusions of blood products, airway interventions such as a breathing
tube, blood pressure medications, or heart rhythm medications. The second chart review will
occur 30 days after surgery. In this review, the presence or absence of the following events
will be ascertained: rapid response team calls, admission to the intensive care unit,
infection, pneumonia, the need for transfusion of 5 or more units of blood within a
three-day period, septic shock, the need for ventilation with a breathing tube, blood clot
in the lung, kidney failure, coma, stroke, heart attack, and death.
The purpose of this study is to define normal and non-normal recovery of patients in the
post-anesthesia care unit (PACU) following major inpatient surgery using the Halo Index, a
measure derived from physiologic parameters collected through the Patient SafetyNet system.
Background Masimo has developed a series of patient monitors designed to improve
perioperative care. The Radical-7 pulse oximeter not only delivers accurate,
artifact-rejecting pulse and oximetry information, but can also be configured to measure
hemoglobin levels and pleth variability index (an assessment of the adequacy of fluid volume
replacement). The rainbow Acoustic Respiration Monitor is able to document presence and
adequacy of ventilation. These parameters have been combined in the SafetyNet Remote
Monitoring system. With this system, data from individual patient monitors are wireless
transmitted to a central station. When certain alarm thresholds are crossed, the system can
automatically notify caregivers. Use of this system on a post-operative floor has shown it
to result in significantly fewer rapid response team (RRT) calls and ICU admission compared
to routine care.
As an enhancement, Masimo has developed the Halo Index. The Halo Index is calculated through
an amalgamation of SafetyNet parameters. The index provides global trend information about
the patient's overall physiologic status. Often patient deterioration occurs over time, with
subtle changes that are appreciated only through trend analysis. Conceptually, the Halo
Index and associated alarms will improve patient care compared with care based on periodic
human assessment and routine monitoring.
While the SafetyNet and Halo index are intended for use on the post-operative patient care
floors with relatively high patient-to-nurse staffing ratios, there may well be monitoring
utility in the PACU, where there is greater patient acuity. It is quite possible that the
Halo index will be able to detect evidence of "mal-recovery" in the PACU and may allow
intervention in such patients that will improve outcome. Before such an assessment of
benefit can be made, it is necessary to define the behavior of the Halo index during
"normal" recovery and to see if the index has a different characteristic in those patients
whose PACU discharge is delayed for medical reasons or those who require unusual medical
interventions.
In addition, significant percentage of patients who undergo major surgery will experience
morbidity in the first 30 days following surgery. Major morbidity can be defined as an
occurrence of one or more of the following postoperative complications: organ space
infection, pneumonia, unplanned intubation, pulmonary embolism, ventilator dependence more
than 48 hours, acute renal failure, stroke/cerebral vascular accident with neurologic
deficit, coma more than 24 hours, cardiac arrest requiring cardiopulmonary resuscitation,
myocardial infarction, transfusion of 5 or more units erythrocytes within 72 hours,
sepsis/septic shock, and mortality.
The chance of developing one or more of these morbid outcomes increases with the size of the
surgery and with the severity of the patient's preexisting medical problems, ranging from
less than 1% to over 50% depending on these factors. It is unknown whether perturbations in
early recovery parameters are associated with postoperative morbidity. If so, it may be
possible to predict who is at increased risk for morbidity based on monitoring during the
early recovery period.
post-anesthesia care unit (PACU) following major inpatient surgery using the Halo Index, a
measure derived from physiologic parameters collected through the Patient SafetyNet system.
Background Masimo has developed a series of patient monitors designed to improve
perioperative care. The Radical-7 pulse oximeter not only delivers accurate,
artifact-rejecting pulse and oximetry information, but can also be configured to measure
hemoglobin levels and pleth variability index (an assessment of the adequacy of fluid volume
replacement). The rainbow Acoustic Respiration Monitor is able to document presence and
adequacy of ventilation. These parameters have been combined in the SafetyNet Remote
Monitoring system. With this system, data from individual patient monitors are wireless
transmitted to a central station. When certain alarm thresholds are crossed, the system can
automatically notify caregivers. Use of this system on a post-operative floor has shown it
to result in significantly fewer rapid response team (RRT) calls and ICU admission compared
to routine care.
As an enhancement, Masimo has developed the Halo Index. The Halo Index is calculated through
an amalgamation of SafetyNet parameters. The index provides global trend information about
the patient's overall physiologic status. Often patient deterioration occurs over time, with
subtle changes that are appreciated only through trend analysis. Conceptually, the Halo
Index and associated alarms will improve patient care compared with care based on periodic
human assessment and routine monitoring.
While the SafetyNet and Halo index are intended for use on the post-operative patient care
floors with relatively high patient-to-nurse staffing ratios, there may well be monitoring
utility in the PACU, where there is greater patient acuity. It is quite possible that the
Halo index will be able to detect evidence of "mal-recovery" in the PACU and may allow
intervention in such patients that will improve outcome. Before such an assessment of
benefit can be made, it is necessary to define the behavior of the Halo index during
"normal" recovery and to see if the index has a different characteristic in those patients
whose PACU discharge is delayed for medical reasons or those who require unusual medical
interventions.
In addition, significant percentage of patients who undergo major surgery will experience
morbidity in the first 30 days following surgery. Major morbidity can be defined as an
occurrence of one or more of the following postoperative complications: organ space
infection, pneumonia, unplanned intubation, pulmonary embolism, ventilator dependence more
than 48 hours, acute renal failure, stroke/cerebral vascular accident with neurologic
deficit, coma more than 24 hours, cardiac arrest requiring cardiopulmonary resuscitation,
myocardial infarction, transfusion of 5 or more units erythrocytes within 72 hours,
sepsis/septic shock, and mortality.
The chance of developing one or more of these morbid outcomes increases with the size of the
surgery and with the severity of the patient's preexisting medical problems, ranging from
less than 1% to over 50% depending on these factors. It is unknown whether perturbations in
early recovery parameters are associated with postoperative morbidity. If so, it may be
possible to predict who is at increased risk for morbidity based on monitoring during the
early recovery period.
Inclusion Criteria:
- planned post-operative admission of 24 hours or greater
- age greater than 18
Exclusion Criteria:
- patients requiring mechanical ventilation with endotracheal intubation or laryngeal
mask airway (oral/nasal airway are acceptable)
- patients receiving transfusion of blood products on arrival to the post-anesthesia
care unit (PACU)
- patients requiring vasoactive medications including vasopressors on arrival to PACU.
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