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Postoperative Respiratory and Activity Monitoring

Postoperative Respiratory and Activity Monitoring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06239831
Enrollment
30
Registered
2024-02-02
Start date
2022-12-22
Completion date
2026-06-22
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoventilation, Hypoxemia, Postoperative Pulmonary Complications

Keywords

hypoventilation, postoperative activity, abdominal surgery, mobilization, predicted minute ventilation (MVPred), accelerometer, chest monitor, postoperative pulmonary complications, surgical outcomes

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.

Interventions

DEVICEExSpiron and ActivPAL Monitors

ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
HypoventilationFirst 3 postoperative daysMinutes per hour of hypoventilation which is defined as \<40% of a predicted minute ventilation volume

Secondary

MeasureTime frameDescription
Duration of high TVThrough postoperative day 3Duration of high tidal volume (VT)
Variability of MVThrough postoperative day 3Variability of minute ventilation (MV)
Variability of VTThrough postoperative day 3Variability of tidal volume (VT)
Variability of RRThrough postoperative day 3Variability of respiratory rate (RR)
Events of Low MVThrough postoperative day 3Total number of events of low minute ventilation (MV)
Events of Low VTThrough postoperative day 3Total number of events of low tidal volume (VT)
Events of Low RRThrough postoperative day 3Total number of events of low respiratory rate (RR)
Percentage of time free of low or high MVThrough postoperative day 3The percentage of hours per day free of any low or high minute ventilation (MV)
Percentage of time free of low or high VTThrough postoperative day 3The percentage of hours per day free of any low or high tidal volume (VT)
Percentage of time free of low or high RRThrough postoperative day 3The percentage of hours per day free of any low or high resting rate (RR).
Duration of low MVThrough postoperative day 3Duration of low minute ventilation (MV)
Duration of low VTThrough postoperative day 3Duration of low tidal volume (VT)
Duration of low RRThrough postoperative day 3Duration of low respiratory rate (RR)
Duration of high MVThrough postoperative day 3Duration of low or high minute ventilation (MV)
Postoperative Pulmonary Complication (PPC) IncidenceThrough postoperative day 7Incidence of Postoperative Pulmonary Complications, or PPCs
Duration of high RRThrough postoperative day 3Duration of high respiratory rate (RR)
Time After Surgery to SittingThrough postoperative day 3Time it takes for the patient to sit in a chair after surgery
Time After Surgery to AmbulatingThrough postoperative day 3Time it takes for the patient to ambulate with and without help
Total Minutes WalkingThrough postoperative day 3Patient's total minutes of walking
Total Walking DistanceThrough postoperative day 3Patient's total walking distance (in meters)
Frequency of AmbulationThrough postoperative day 3How many times the patient gets up to ambulate
Time Spent in BedThrough postoperative day 3After the surgery, the patient's minutes spent in bed
Time Spent in SittingThrough postoperative day 3After the surgery, the patient's minutes spent sitting
Time Spent StandingThrough postoperative day 3After the surgery, the patient's minutes spent standing
Time Spent WalkingThrough postoperative day 3After the surgery, the patient's minutes spent walking
Average Speed of AmbulationThrough postoperative day 3After the surgery, the patient's average speed of ambulating
First Postoperative Day Achieving Independent AmbulationThrough postoperative day 3After the surgery, the patient's first day of ambulating by his or herself for 30 meters
Metabolic Equivalent of Task (MET) Score of Physical ActivityThrough postoperative day 3After the surgery, the patient's intensity of physical activity measured in METs
Other complicationsThrough postoperative day 7Incidence of any non-respiratory complications
Adverse eventsThrough postoperative day 7Incidence of any adverse events
Postoperative Pulmonary Complication (PPC) SeverityThrough postoperative day 7Postoperative 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)

Countries

United States

Contacts

Primary ContactEmily G. Helmer
emily.helmer@cuanschutz.edu(303)-724-2938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026