Postoperative Respiratory and Activity Monitoring

Recruiting

• Conditions: Hypoventilation; Hypoxemia; Postoperative Pulmonary Complications

• 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.

Study Timeline

• Study Start: 2022-12-22
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-12-22
• Study Completion: 2026-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)
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
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)
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)
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)
Total Minutes Walking	Through postoperative day 3	Patient's total minutes of walking
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 low RR	Through postoperative day 3	Duration of low respiratory rate (RR)
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