An observational study in Hypoventilation, Hypoxemia and Postoperative Pulmonary Complications, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by University of Colorado, Denver · Observational
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.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 28 observational studies indexed under Hypoventilation.
Browse Hypoventilation studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: ExSpiron and ActivPAL Monitors
ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh
Hypoventilation
Minutes per hour of hypoventilation which is defined as \<40% of a predicted minute ventilation volume
Time frame: First 3 postoperative days
Variability of MV
Variability of minute ventilation (MV)
Time frame: Through postoperative day 3
Variability of VT
Variability of tidal volume (VT)
Time frame: Through postoperative day 3
Variability of RR
Variability of respiratory rate (RR)
Time frame: Through postoperative day 3
Events of Low MV
Total number of events of low minute ventilation (MV)
Time frame: Through postoperative day 3
Events of Low VT
Total number of events of low tidal volume (VT)
Time frame: Through postoperative day 3
Events of Low RR
Total number of events of low respiratory rate (RR)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Through postoperative day 3
Duration of low MV
Duration of low minute ventilation (MV)
Time frame: Through postoperative day 3
Duration of low VT
Duration of low tidal volume (VT)
Time frame: Through postoperative day 3
Duration of low RR
Duration of low respiratory rate (RR)
Time frame: Through postoperative day 3
Duration of high MV
Duration of low or high minute ventilation (MV)
Time frame: Through postoperative day 3
Duration of high TV
Duration of high tidal volume (VT)
Time frame: Through postoperative day 3
Duration of high RR
Duration of high respiratory rate (RR)
Time frame: Through postoperative day 3
Postoperative Pulmonary Complication (PPC) Incidence
Incidence of Postoperative Pulmonary Complications, or PPCs
Time frame: 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)
Time frame: Through postoperative day 7
Time After Surgery to Sitting
Time it takes for the patient to sit in a chair after surgery
Time frame: Through postoperative day 3
Time After Surgery to Ambulating
Time it takes for the patient to ambulate with and without help
Time frame: Through postoperative day 3
Total Minutes Walking
Patient's total minutes of walking
Time frame: Through postoperative day 3
Total Walking Distance
Patient's total walking distance (in meters)
Time frame: Through postoperative day 3
Frequency of Ambulation
How many times the patient gets up to ambulate
Time frame: Through postoperative day 3
Time Spent in Bed
After the surgery, the patient's minutes spent in bed
Time frame: Through postoperative day 3
Time Spent in Sitting
After the surgery, the patient's minutes spent sitting
Time frame: Through postoperative day 3
Time Spent Standing
After the surgery, the patient's minutes spent standing
Time frame: Through postoperative day 3
Time Spent Walking
After the surgery, the patient's minutes spent walking
Time frame: Through postoperative day 3
Average Speed of Ambulation
After the surgery, the patient's average speed of ambulating
Time frame: 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
Time frame: 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
Time frame: Through postoperative day 3
Other complications
Incidence of any non-respiratory complications
Time frame: Through postoperative day 7
Adverse events
Incidence of any adverse events
Time frame: Through postoperative day 7
Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Dec 2025, 36 months after the start.
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