Postoperative Respiratory and Activity Monitoring
April 29, 2025 updated by: University of Colorado, Denver
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emily G. Helmer
- Phone Number: (303)-724-2938
- Email: emily.helmer@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- UC Health
-
Contact:
- Emily G. Helmer
- Phone Number: 303-724-2938
- Email: emily.helmer@cuanschutz.edu
-
Principal Investigator:
- Ana Fernandez-Bustamante, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypoventilation
Time Frame: First 3 postoperative days
|
Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume
|
First 3 postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variability of MV
Time Frame: Through postoperative day 3
|
Variability of minute ventilation (MV)
|
Through postoperative day 3
|
|
Variability of VT
Time Frame: Through postoperative day 3
|
Variability of tidal volume (VT)
|
Through postoperative day 3
|
|
Variability of RR
Time Frame: Through postoperative day 3
|
Variability of respiratory rate (RR)
|
Through postoperative day 3
|
|
Events of Low MV
Time Frame: Through postoperative day 3
|
Total number of events of low minute ventilation (MV)
|
Through postoperative day 3
|
|
Events of Low VT
Time Frame: Through postoperative day 3
|
Total number of events of low tidal volume (VT)
|
Through postoperative day 3
|
|
Events of Low RR
Time Frame: Through postoperative day 3
|
Total number of events of low respiratory rate (RR)
|
Through postoperative day 3
|
|
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)
|
Through postoperative day 3
|
|
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)
|
Through postoperative day 3
|
|
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).
|
Through postoperative day 3
|
|
Duration of low MV
Time Frame: Through postoperative day 3
|
Duration of low minute ventilation (MV)
|
Through postoperative day 3
|
|
Duration of low VT
Time Frame: Through postoperative day 3
|
Duration of low tidal volume (VT)
|
Through postoperative day 3
|
|
Duration of low RR
Time Frame: Through postoperative day 3
|
Duration of low respiratory rate (RR)
|
Through postoperative day 3
|
|
Duration of high MV
Time Frame: Through postoperative day 3
|
Duration of low or high minute ventilation (MV)
|
Through postoperative day 3
|
|
Duration of high TV
Time Frame: Through postoperative day 3
|
Duration of high tidal volume (VT)
|
Through postoperative day 3
|
|
Duration of high RR
Time Frame: Through postoperative day 3
|
Duration of high respiratory rate (RR)
|
Through postoperative day 3
|
|
Postoperative Pulmonary Complication (PPC) Incidence
Time Frame: Through postoperative day 7
|
Incidence of Postoperative Pulmonary Complications, or PPCs
|
Through postoperative day 7
|
|
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)
|
Through postoperative day 7
|
|
Time After Surgery to Sitting
Time Frame: Through postoperative day 3
|
Time it takes for the patient to sit in a chair after surgery
|
Through postoperative day 3
|
|
Time After Surgery to Ambulating
Time Frame: Through postoperative day 3
|
Time it takes for the patient to ambulate with and without help
|
Through postoperative day 3
|
|
Total Minutes Walking
Time Frame: Through postoperative day 3
|
Patient's total minutes of walking
|
Through postoperative day 3
|
|
Total Walking Distance
Time Frame: Through postoperative day 3
|
Patient's total walking distance (in meters)
|
Through postoperative day 3
|
|
Frequency of Ambulation
Time Frame: Through postoperative day 3
|
How many times the patient gets up to ambulate
|
Through postoperative day 3
|
|
Time Spent in Bed
Time Frame: Through postoperative day 3
|
After the surgery, the patient's minutes spent in bed
|
Through postoperative day 3
|
|
Time Spent in Sitting
Time Frame: Through postoperative day 3
|
After the surgery, the patient's minutes spent sitting
|
Through postoperative day 3
|
|
Time Spent Standing
Time Frame: Through postoperative day 3
|
After the surgery, the patient's minutes spent standing
|
Through postoperative day 3
|
|
Time Spent Walking
Time Frame: Through postoperative day 3
|
After the surgery, the patient's minutes spent walking
|
Through postoperative day 3
|
|
Average Speed of Ambulation
Time Frame: Through postoperative day 3
|
After the surgery, the patient's average speed of ambulating
|
Through postoperative day 3
|
|
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
|
Through postoperative day 3
|
|
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
|
Through postoperative day 3
|
|
Other complications
Time Frame: Through postoperative day 7
|
Incidence of any non-respiratory complications
|
Through postoperative day 7
|
|
Adverse events
Time Frame: Through postoperative day 7
|
Incidence of any adverse events
|
Through postoperative day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Fernandez-Bustamante, MD, PhD, University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995. Erratum In: JAMA Surg. 2022 May 1;157(5):460. doi: 10.1001/jamasurg.2022.0376.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2022
Primary Completion (Estimated)
December 22, 2025
Study Completion (Estimated)
June 22, 2026
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
January 25, 2024
First Posted (Actual)
February 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-2268
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.