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NCT01811433 · ClinicalTrials.gov registry record
Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery
A clinical trial, sponsored by Donald Mathews.
- Completed
- Registry status
- 500
- Enrollment target
NCT01811433 is a clinical trial that has completed, run by Donald Mathews. The registered enrollment target is 500 participants.
The verdict
NCT01811433 has completed, sponsored by Donald Mathews.
- COMPLETED
- Registry status
- 500 participants
- Enrollment target
Study 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, admis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01811433
The ClinicalTrials.gov registry entry for NCT01811433 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Donald Mathews, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01811433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01811433 about?
NCT01811433 is a clinical study titled "Halo Index and Adaptive Alarm Thresholds During Routine PACU Inpatient Care: "Normal" vs. "Non-normal" Recovery". 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 w...
What is the current status of trial NCT01811433?
This trial is currently completed. The enrollment target is 500 participants. The study started on 2013-03. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01811433?
This trial is sponsored by Donald Mathews, which has 2 total clinical trials registered on ClinicalTrials.gov.
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