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Clinical Trials/NCT06239831
NCT06239831RecruitingNot Applicable

Postoperative Respiratory and Activity Monitoring

University of Colorado, Denver1 site in 1 country30 target enrollmentStarted: December 22, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Hypoventilation

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Outcomes

Primary Outcomes

Hypoventilation

Time Frame: First 3 postoperative days

Minutes per hour of hypoventilation which is defined as \<40% of a predicted minute ventilation volume

Secondary Outcomes

  • Metabolic Equivalent of Task (MET) Score of Physical Activity(Through postoperative day 3)
  • First Postoperative Day Achieving Independent Ambulation(Through postoperative day 3)
  • Other complications(Through postoperative day 7)
  • Variability of RR(Through postoperative day 3)
  • Percentage of time free of low or high MV(Through postoperative day 3)
  • Postoperative Pulmonary Complication (PPC) Severity(Through postoperative day 7)
  • Time After Surgery to Ambulating(Through postoperative day 3)
  • Total Minutes Walking(Through postoperative day 3)
  • Frequency of Ambulation(Through postoperative day 3)
  • Time Spent in Bed(Through postoperative day 3)
  • Time Spent in Sitting(Through postoperative day 3)
  • Duration of high MV(Through postoperative day 3)
  • Adverse events(Through postoperative day 7)
  • Variability of MV(Through postoperative day 3)
  • Variability of VT(Through postoperative day 3)
  • Events of Low MV(Through postoperative day 3)
  • Events of Low VT(Through postoperative day 3)
  • Events of Low RR(Through postoperative day 3)
  • Percentage of time free of low or high VT(Through postoperative day 3)
  • Percentage of time free of low or high RR(Through postoperative day 3)
  • Duration of low MV(Through postoperative day 3)
  • Duration of low VT(Through postoperative day 3)
  • Duration of low RR(Through postoperative day 3)
  • Duration of high RR(Through postoperative day 3)
  • Duration of high TV(Through postoperative day 3)
  • Postoperative Pulmonary Complication (PPC) Incidence(Through postoperative day 7)
  • Time After Surgery to Sitting(Through postoperative day 3)
  • Total Walking Distance(Through postoperative day 3)
  • Average Speed of Ambulation(Through postoperative day 3)
  • Time Spent Standing(Through postoperative day 3)
  • Time Spent Walking(Through postoperative day 3)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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