Patients Recovering From Inpatient SurgeryHaloNCT01811433
Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery
An observational study of Patients Recovering From Inpatient Surgery, run by Donald Mathews at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Recovering From Inpatient Surgery
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for surgery with a planned inpatient stay of 24 hours or greater.
Who may be able to join
- planned post-operative admission of 24 hours or greater
- age greater than 18
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care
Burlington, Vermont, 05401
About this study
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Postoperative Period, Anesthesia Recovery Period, Postoperative Complications, Pulse Oximetry
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal vs. non-normal recovery after surgery as defined by the Halo Index.
To evaluate whether the Halo Index shows a predictable and reproducible pattern in those patients who experience "normal" post-anesthesia care unit (PACU) recovery following major inpatient surgery, and that this "normal" pattern is different from those who experience "non-normal" recovery.
Measured: 30 days after surgery
Secondary outcomes (1)
Association between postoperative morbidity and non-normal recovery from surgery.
To determine whether there is an association between major 30-day post-op morbidity and the incidence of "non-normal" recovery, and whether PACU Halo scores are predictive of postoperative 30-day morbidity.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Recovering From Inpatient SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donald Mathews
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Sponsor-investigator, Donald Mathews, University of Vermont
- Investigators
- Donald M Mathews, M.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811433
- Sponsor's protocol ID
- Masimo 27353
- Acronym
- Halo
- Status last verified
- Sep 2014
- First submitted
- 12 Mar 2013
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.
PubMed 20098128Dalton JE, Kurz A, Turan A, Mascha EJ, Sessler DI, Saager L. Development and validation of a risk quantification index for 30-day postoperative mortality and morbidity in noncardiac surgical patients. Anesthesiology. 2011 Jun;114(6):1336-44. doi: 10.1097/ALN.0b013e318219d5f9.
PubMed 21519230
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery
- ClinicalTrials.gov ID
- NCT01811433
- Acronym / sponsor ID
- Halo / Masimo 27353
- Keywords
- Postoperative Period, Anesthesia Recovery Period, Postoperative Complications, Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Donald MathewsUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for surgery with a planned inpatient stay of 24 hours or greater.
Key inclusion criteria (2 listed)
- planned post-operative admission of 24 hours or greater
- age greater than 18
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normal vs. non-normal recovery after surgery as defined by the Halo Index.
Time frame: 30 days after surgery
To evaluate whether the Halo Index shows a predictable and reproducible pattern in those patients who experience "normal" post-anesthesia care unit (PACU) recovery following major inpatient surgery, and that this "normal" pattern is different from those who experience "non-normal" recovery.
1 secondary outcome
Association between postoperative morbidity and non-normal recovery from surgery.
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
- Background: PubMed 20098128Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.
- Background: PubMed 21519230Dalton JE, Kurz A, Turan A, Mascha EJ, Sessler DI, Saager L. Development and validation of a risk quantification index for 30-day postoperative mortality and morbidity in noncardiac surgical patients. Anesthesiology. 2011 Jun;114(6):1336-44. doi: 10.1097/ALN.0b013e318219d5f9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M Mathews, M.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Recovering From Inpatient Surgery, run by Donald Mathews at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal vs. non-normal recovery after surgery as defined by the Halo Index. (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01811433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.