Postoperative Respiratory and Activity Monitoring

Hypoxemia Clinical Trial

Official title:

Postoperative Respiratory and Activity Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239831
• Other study ID #: 22-2268
• Status: Recruiting
• Start date: December 22, 2022
• Est. completion date: June 22, 2025

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Emily G. Helmer
• Phone: (303)-724-2938
• Email: emily.helmer[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 22, 2025
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypoventilation
• Hypoxemia
• Hypoxia
• Postoperative Pulmonary Complications

Intervention

Device:
• ExSpiron and ActivPAL Monitors
ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh

Locations

Country	Name	City	State
United States	UC Health	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (61)

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoventilation	Minutes per hour of hypoventilation which is defined as <40% of a predicted minute ventilation volume	First 3 postoperative days
Secondary	Variability of MV	Variability of minute ventilation (MV)	Through postoperative day 3
Secondary	Variability of VT	Variability of tidal volume (VT)	Through postoperative day 3
Secondary	Variability of RR	Variability of respiratory rate (RR)	Through postoperative day 3
Secondary	Events of Low MV	Total number of events of low minute ventilation (MV)	Through postoperative day 3
Secondary	Events of Low VT	Total number of events of low tidal volume (VT)	Through postoperative day 3
Secondary	Events of Low RR	Total number of events of low respiratory rate (RR)	Through postoperative day 3
Secondary	Percentage of time free of low or high MV	The percentage of hours per day free of any low or high minute ventilation (MV)	Through postoperative day 3
Secondary	Percentage of time free of low or high VT	The percentage of hours per day free of any low or high tidal volume (VT)	Through postoperative day 3
Secondary	Percentage of time free of low or high RR	The percentage of hours per day free of any low or high resting rate (RR).	Through postoperative day 3
Secondary	Duration of low MV	Duration of low minute ventilation (MV)	Through postoperative day 3
Secondary	Duration of low VT	Duration of low tidal volume (VT)	Through postoperative day 3
Secondary	Duration of low RR	Duration of low respiratory rate (RR)	Through postoperative day 3
Secondary	Duration of high MV	Duration of low or high minute ventilation (MV)	Through postoperative day 3
Secondary	Duration of high TV	Duration of high tidal volume (VT)	Through postoperative day 3
Secondary	Duration of high RR	Duration of high respiratory rate (RR)	Through postoperative day 3
Secondary	Postoperative Pulmonary Complication (PPC) Incidence	Incidence of Postoperative Pulmonary Complications, or PPCs	Through postoperative day 7
Secondary	Postoperative Pulmonary Complication (PPC) Severity	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
Secondary	Time After Surgery to Sitting	Time it takes for the patient to sit in a chair after surgery	Through postoperative day 3
Secondary	Time After Surgery to Ambulating	Time it takes for the patient to ambulate with and without help	Through postoperative day 3
Secondary	Total Minutes Walking	Patient's total minutes of walking	Through postoperative day 3
Secondary	Total Walking Distance	Patient's total walking distance (in meters)	Through postoperative day 3
Secondary	Frequency of Ambulation	How many times the patient gets up to ambulate	Through postoperative day 3
Secondary	Time Spent in Bed	After the surgery, the patient's minutes spent in bed	Through postoperative day 3
Secondary	Time Spent in Sitting	After the surgery, the patient's minutes spent sitting	Through postoperative day 3
Secondary	Time Spent Standing	After the surgery, the patient's minutes spent standing	Through postoperative day 3
Secondary	Time Spent Walking	After the surgery, the patient's minutes spent walking	Through postoperative day 3
Secondary	Average Speed of Ambulation	After the surgery, the patient's average speed of ambulating	Through postoperative day 3
Secondary	First Postoperative Day Achieving Independent Ambulation	After the surgery, the patient's first day of ambulating by his or herself for 30 meters	Through postoperative day 3
Secondary	Metabolic Equivalent of Task (MET) Score of Physical Activity	After the surgery, the patient's intensity of physical activity measured in METs	Through postoperative day 3
Secondary	Other complications	Incidence of any non-respiratory complications	Through postoperative day 7
Secondary	Adverse events	Incidence of any adverse events	Through postoperative day 7