Postoperative Respiratory and Activity Monitoring
- Conditions
- HypoventilationHypoxemiaPostoperative Pulmonary Complications
- Interventions
- Device: ExSpiron and ActivPAL Monitors
- Registration Number
- NCT06239831
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Must be 18 or older
- Must be undergoing abdominal surgery
- Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)
- Anyone under 18
- Anyone not undergoing abdominal surgery
- Anyone that is not high-risk for PPCs (ARISCAT score less than 26)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Postoperative monitoring ExSpiron and ActivPAL Monitors 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.
- Primary Outcome Measures
Name Time Method Hypoventilation First 3 postoperative days Minutes per hour of hypoventilation which is defined as \<40% of a predicted minute ventilation volume
- Secondary Outcome Measures
Name Time Method Variability of RR Through postoperative day 3 Variability of respiratory rate (RR)
Percentage of time free of low or high MV Through postoperative day 3 The percentage of hours per day free of any low or high minute ventilation (MV)
Postoperative Pulmonary Complication (PPC) Severity 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 Ambulating Through postoperative day 3 Time it takes for the patient to ambulate with and without help
Total Minutes Walking Through postoperative day 3 Patient's total minutes of walking
Duration of low RR Through postoperative day 3 Duration of low respiratory rate (RR)
Variability of MV Through postoperative day 3 Variability of minute ventilation (MV)
Variability of VT Through postoperative day 3 Variability of tidal volume (VT)
Events of Low MV Through postoperative day 3 Total number of events of low minute ventilation (MV)
Events of Low VT Through postoperative day 3 Total number of events of low tidal volume (VT)
Events of Low RR Through postoperative day 3 Total number of events of low respiratory rate (RR)
Percentage of time free of low or high VT 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 Through postoperative day 3 The percentage of hours per day free of any low or high resting rate (RR).
Duration of low MV Through postoperative day 3 Duration of low minute ventilation (MV)
Duration of low VT Through postoperative day 3 Duration of low tidal volume (VT)
Frequency of Ambulation Through postoperative day 3 How many times the patient gets up to ambulate
Time Spent in Bed Through postoperative day 3 After the surgery, the patient's minutes spent in bed
Time Spent in Sitting Through postoperative day 3 After the surgery, the patient's minutes spent sitting
Duration of high RR Through postoperative day 3 Duration of high respiratory rate (RR)
Duration of high MV Through postoperative day 3 Duration of low or high minute ventilation (MV)
Duration of high TV Through postoperative day 3 Duration of high tidal volume (VT)
Postoperative Pulmonary Complication (PPC) Incidence Through postoperative day 7 Incidence of Postoperative Pulmonary Complications, or PPCs
Time After Surgery to Sitting Through postoperative day 3 Time it takes for the patient to sit in a chair after surgery
Total Walking Distance Through postoperative day 3 Patient's total walking distance (in meters)
Time Spent Standing Through postoperative day 3 After the surgery, the patient's minutes spent standing
Time Spent Walking Through postoperative day 3 After the surgery, the patient's minutes spent walking
Average Speed of Ambulation Through postoperative day 3 After the surgery, the patient's average speed of ambulating
Adverse events Through postoperative day 7 Incidence of any adverse events
Metabolic Equivalent of Task (MET) Score of Physical Activity Through postoperative day 3 After the surgery, the patient's intensity of physical activity measured in METs
First Postoperative Day Achieving Independent Ambulation Through postoperative day 3 After the surgery, the patient's first day of ambulating by his or herself for 30 meters
Other complications Through postoperative day 7 Incidence of any non-respiratory complications
Trial Locations
- Locations (1)
UC Health
🇺🇸Aurora, Colorado, United States