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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.
Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.
Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative monitoring | ActivPAL accelerometer will be placed on the chest and thigh, an ExSpiron monitor placed on the chest, and the patient will be observed for three days, until fully ambulatory (able to walk 30 meters without assistance with or without a walker), or until discharge; whichever comes earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExSpiron and ActivPAL Monitors | Device | ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoventilation | Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume | First 3 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Variability of MV | Variability of minute ventilation (MV) | Through postoperative day 3 |
| Variability of VT | Variability of tidal volume (VT) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over the age of 18 undergoing abdominal surgery at the University of Colorado Health Hospital (UCHealth) that it high-risk for postoperative pulmonary complications (PPCs).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily G. Helmer | Contact | (303)-724-2938 | emily.helmer@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Fernandez-Bustamante, MD, PhD | University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37023031 | Background | Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023. | |
| 8770719 | Background |
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| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| Through postoperative day 3 |
| Variability of RR | Variability of respiratory rate (RR) | Through postoperative day 3 |
| Events of Low MV | Total number of events of low minute ventilation (MV) | Through postoperative day 3 |
| Events of Low VT | Total number of events of low tidal volume (VT) | Through postoperative day 3 |
| Events of Low RR | Total number of events of low respiratory rate (RR) | Through postoperative day 3 |
| Percentage of time free of low or high MV | The percentage of hours per day free of any low or high minute ventilation (MV) | Through postoperative day 3 |
| Percentage of time free of low or high VT | The percentage of hours per day free of any low or high tidal volume (VT) | Through postoperative day 3 |
| Percentage of time free of low or high RR | The percentage of hours per day free of any low or high resting rate (RR). | Through postoperative day 3 |
| Duration of low MV | Duration of low minute ventilation (MV) | Through postoperative day 3 |
| Duration of low VT | Duration of low tidal volume (VT) | Through postoperative day 3 |
| Duration of low RR | Duration of low respiratory rate (RR) | Through postoperative day 3 |
| Duration of high MV | Duration of low or high minute ventilation (MV) | Through postoperative day 3 |
| Duration of high TV | Duration of high tidal volume (VT) | Through postoperative day 3 |
| Duration of high RR | Duration of high respiratory rate (RR) | Through postoperative day 3 |
| Postoperative Pulmonary Complication (PPC) Incidence | Incidence of Postoperative Pulmonary Complications, or PPCs | Through postoperative day 7 |
| Postoperative Pulmonary Complication (PPC) Severity | Postoperative Pulmonary Complications, or PPCs, will be observed in their severity. PPC severity is defined as the most serious from Grade 0 (none) to Grade 4 (severe) | Through postoperative day 7 |
| Time After Surgery to Sitting | Time it takes for the patient to sit in a chair after surgery | Through postoperative day 3 |
| Time After Surgery to Ambulating | Time it takes for the patient to ambulate with and without help | Through postoperative day 3 |
| Total Minutes Walking | Patient's total minutes of walking | Through postoperative day 3 |
| Total Walking Distance | Patient's total walking distance (in meters) | Through postoperative day 3 |
| Frequency of Ambulation | How many times the patient gets up to ambulate | Through postoperative day 3 |
| Time Spent in Bed | After the surgery, the patient's minutes spent in bed | Through postoperative day 3 |
| Time Spent in Sitting | After the surgery, the patient's minutes spent sitting | Through postoperative day 3 |
| Time Spent Standing | After the surgery, the patient's minutes spent standing | Through postoperative day 3 |
| Time Spent Walking | After the surgery, the patient's minutes spent walking | Through postoperative day 3 |
| Average Speed of Ambulation | After the surgery, the patient's average speed of ambulating | Through postoperative day 3 |
| First Postoperative Day Achieving Independent Ambulation | After the surgery, the patient's first day of ambulating by his or herself for 30 meters | Through postoperative day 3 |
| Metabolic Equivalent of Task (MET) Score of Physical Activity | After the surgery, the patient's intensity of physical activity measured in METs | Through postoperative day 3 |
| Other complications | Incidence of any non-respiratory complications | Through postoperative day 7 |
| Adverse events | Incidence of any adverse events | Through postoperative day 7 |
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