REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

March 4, 2024 updated by: University of Colorado, Denver

Postoperative Utilization of Incentive Spirometry With and Without Electronic Patient Reminders in the Post-Anesthesia Care Unit (PACU)

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pragmatic single-center alternating cluster study. We will enroll adult patients who require general anesthesia for surgery and receive an incentive spirometry device during their PACU stay. Automatic alarms to perform incentive spirometry will be set to either "ON" or "OFF" in alternating weeks. The hypothesis is that patients receiving automatic audible and visual alarms will have increased rates of adequate incentive spirometry breaths compared to patients receiving no alarms.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • be 18 years or older;
  • have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia;
  • have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff;
  • not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor.

Exclusion Criteria:

  • have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor;
  • have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device);
  • are a part of a vulnerable population (e.g., pregnant, minors, prisoners).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alarm "ON" Cohort
The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Device: Alarms
The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Other Names:
  • Auditory and visual reminders
Placebo Comparator: Alarm "OFF" Cohort
The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.
Device: Alarms
The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.
Other Names:
  • Auditory and visual reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adequate IS breaths achieved in PACU
Time Frame: PACU stay (up to 3 hours)
Rate of adequate incentive spirometry breaths achieved by patients per hour for up to 3 hours during the PACU stay
PACU stay (up to 3 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of IS breaths attempted in PACU
Time Frame: PACU stay (up to 3 hours)
Rate of incentive spirometry breaths attempted by patients per hour for up to 3 hours during the PACU stay
PACU stay (up to 3 hours)
Time to first adequate IS breath
Time Frame: PACU stay (up to 3 hours)
The time it takes for the patient to achieve their first adequate IS breath, from the moment of being provided the IS device and instructions of use onward, during their PACU stay
PACU stay (up to 3 hours)
Duration of postoperative O2 therapy
Time Frame: Hospital stay (up to first 3 postoperative days)
The total postoperative length of oxygen therapy use from the time the patient arrives to PACU to the end of their O2 therapy
Hospital stay (up to first 3 postoperative days)
Presence of postoperative pulmonary complications
Time Frame: Hospital stay (up to first 3 postoperative days)
The number of study participants developing any pulmonary complications (including pneumonia, need for non-invasive ventilation (CPAP/BiPAP or reintubation for any reason and any duration) during the first 3 postoperative days
Hospital stay (up to first 3 postoperative days)
Individual postoperative pulmonary complications
Time Frame: Hospital stay (up to first 3 postoperative days)
The number of study participants developing each pulmonary complication (pneumonia, need for non-invasive ventilation (CPAP/BiPAP or reintubation for any reason and any duration) during the first 3 postoperative days
Hospital stay (up to first 3 postoperative days)
Need for ICU Admission after PACU
Time Frame: Hospital stay (up to first 3 postoperative days)
The frequency of patients requiring ICU admission immediately after their PACU stay
Hospital stay (up to first 3 postoperative days)
PACU Length of Stay
Time Frame: PACU stay
The length of stay in the PACU
PACU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Ana Fernandez-Bustamante, MD, PhD, University of Colorado School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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