Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery

NCT01811433 | Completed

• 1 other identifier: Masimo 27353
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Patients Recovering From Inpatient Surgery

Keywords

Postoperative Period; Anesthesia Recovery Period; Postoperative Complications; Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after surgery

Secondary Outcomes (1)

• Association between postoperative morbidity and non-normal recovery from surgery.

  30 days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for surgery with a planned inpatient stay of 24 hours or greater.

You may qualify if:

• planned post-operative admission of 24 hours or greater
• age greater than 18

You may not qualify if:

• 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.

Sponsors & Collaborators

• Donald Mathews: lead
• Masimo Corporation: collaborator

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

• 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.

  PMID: 20098128 BACKGROUND

• Dalton 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.

  PMID: 21519230 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald M Mathews, M.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist and Professor of Anesthesiology

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (1)