Postoperative Respiratory and Activity Monitoring

NCT06239831 | Recruiting FDA Device

• 1 other identifier: 22-2268
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hypoventilation

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

  First 3 postoperative days

Secondary Outcomes (31)

• Variability of MV

  Through postoperative day 3

• Variability of VT

  Through postoperative day 3

• Variability of RR

  Through postoperative day 3

• Events of Low MV

  Through postoperative day 3

• Events of Low VT

  Through postoperative day 3

Study Arms (1)

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.

Device: ExSpiron and ActivPAL Monitors

Interventions

ExSpiron and ActivPAL Monitors DEVICE

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

Postoperative monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Must be 18 or older
• Must be undergoing abdominal surgery
• Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)

You may not qualify if:

• Anyone under 18
• Anyone not undergoing abdominal surgery
• Anyone that is not high-risk for PPCs (ARISCAT score less than 26)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

UC Health

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (61)

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MeSH Terms

Conditions

Hypoventilation; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Fernandez-Bustamante, MD, PhD

  University of Colorado Anschutz Medical Campus, University of Colorado Health Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily G. Helmer

CONTACT

(303)-724-2938; emily.helmer@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: February 2, 2024
• Study Start: December 22, 2022
• Primary Completion: December 22, 2025
• Study Completion (Estimated): June 22, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)