Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06239831

Conditions

Hypoventilation

Hypoxemia

Postoperative Pulmonary Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ExSpiron and ActivPAL Monitors

Study Details

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

Study ID

NCT06239831

Start date

Dec 22, 2022

Status verified date

Apr, 2025

Completion date

Jun 22, 2026

Anticipated

Primary completion date

Dec 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

ExSpiron and ActivPAL Monitors

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

Primary outcome measure

  • Hypoventilation [ Time Frame: First 3 postoperative days ]

Central Contacts and Locations

Central contacts

Emily G. Helmer

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

Locations

UC Health

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily G. Helmer

303-724-2938emily.helmer@cuanschutz.edu

Principal Investigator:

Ana Fernandez-Bustamante, MD, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-30.