UC Health
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Ana Fernandez-Bustamante, MD, PhD
PRINCIPAL_INVESTIGATOR
Emily G. Helmer
CONTACT
Recruiting
NCT Number: NCT06239831
Postoperative Respiratory and Activity Monitoring
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Must be 18 or older
- Must be undergoing abdominal surgery
- Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)
Exclusion criteria
- Anyone under 18
- Anyone not undergoing abdominal surgery
- Anyone that is not high-risk for PPCs (ARISCAT score less than 26)
Treatment and study plan
ExSpiron and ActivPAL Monitors
DeviceExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh
Primary outcomes
-
Hypoventilation
Time frame: First 3 postoperative days
Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume
Secondary outcomes
-
Variability of MV
Time frame: Through postoperative day 3
Variability of minute ventilation (MV)
-
Variability of VT
Time frame: Through postoperative day 3
Variability of tidal volume (VT)
-
Variability of RR
Time frame: Through postoperative day 3
Variability of respiratory rate (RR)
-
Events of Low MV
Time frame: Through postoperative day 3
Total number of events of low minute ventilation (MV)
-
Events of Low VT
Time frame: Through postoperative day 3
Total number of events of low tidal volume (VT)
-
Events of Low RR
Time frame: Through postoperative day 3
Total number of events of low respiratory rate (RR)
-
Percentage of time free of low or high MV
Time frame: Through postoperative day 3
The percentage of hours per day free of any low or high minute ventilation (MV)
-
Percentage of time free of low or high VT
Time frame: Through postoperative day 3
The percentage of hours per day free of any low or high tidal volume (VT)
-
Percentage of time free of low or high RR
Time frame: Through postoperative day 3
The percentage of hours per day free of any low or high resting rate (RR).
-
Duration of low MV
Time frame: Through postoperative day 3
Duration of low minute ventilation (MV)
-
Duration of low VT
Time frame: Through postoperative day 3
Duration of low tidal volume (VT)
-
Duration of low RR
Time frame: Through postoperative day 3
Duration of low respiratory rate (RR)
-
Duration of high MV
Time frame: Through postoperative day 3
Duration of low or high minute ventilation (MV)
-
Duration of high TV
Time frame: Through postoperative day 3
Duration of high tidal volume (VT)
-
Duration of high RR
Time frame: Through postoperative day 3
Duration of high respiratory rate (RR)
-
Postoperative Pulmonary Complication (PPC) Incidence
Time frame: Through postoperative day 7
Incidence of Postoperative Pulmonary Complications, or PPCs
-
Postoperative Pulmonary Complication (PPC) Severity
Time frame: Through postoperative day 7
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 After Surgery to Sitting
Time frame: Through postoperative day 3
Time it takes for the patient to sit in a chair after surgery
-
Time After Surgery to Ambulating
Time frame: Through postoperative day 3
Time it takes for the patient to ambulate with and without help
-
Total Minutes Walking
Time frame: Through postoperative day 3
Patient's total minutes of walking
-
Total Walking Distance
Time frame: Through postoperative day 3
Patient's total walking distance (in meters)
-
Frequency of Ambulation
Time frame: Through postoperative day 3
How many times the patient gets up to ambulate
-
Time Spent in Bed
Time frame: Through postoperative day 3
After the surgery, the patient's minutes spent in bed
-
Time Spent in Sitting
Time frame: Through postoperative day 3
After the surgery, the patient's minutes spent sitting
-
Time Spent Standing
Time frame: Through postoperative day 3
After the surgery, the patient's minutes spent standing
-
Time Spent Walking
Time frame: Through postoperative day 3
After the surgery, the patient's minutes spent walking
-
Average Speed of Ambulation
Time frame: Through postoperative day 3
After the surgery, the patient's average speed of ambulating
-
First Postoperative Day Achieving Independent Ambulation
Time frame: Through postoperative day 3
After the surgery, the patient's first day of ambulating by his or herself for 30 meters
-
Metabolic Equivalent of Task (MET) Score of Physical Activity
Time frame: Through postoperative day 3
After the surgery, the patient's intensity of physical activity measured in METs
-
Other complications
Time frame: Through postoperative day 7
Incidence of any non-respiratory complications
-
Adverse events
Time frame: Through postoperative day 7
Incidence of any adverse events
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Colorado, Denver
Other
Collaborators
- Brigham and Women's Hospital
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Feb 2, 2024
- Registry last updated
- Apr 30, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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