Health TrialsbyHealthPanel

Reminder-enhanced Incentive Spirometry Evaluation

ConditionHypoxemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

The purpose of this study is to test whether automatic reminders with a light and a soft sound help patients improve deep breathing exercises after surgery. These breathing exercises are routinely done with the help of a plastic device that you attach to your mouth and you take a deep breath. These exercises are routinely recommended after major surgery to improve the oxygen level in your blood and reduce other respiratory problems.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years

Planned non-cardiac surgery under general anesthesia with at least one night of hospitalization expected

Preoperative ARISCAT risk score ≥26

Signed informed consent

Disqualifiers

Inability to perform IS due to refusal, cognitive impairment, neuromuscular weakness, anatomical, or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometer)

Have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual IS reminders

Are part of a vulnerable population (minors, pregnant, prisoners)

Lack of informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alarms ON

    Device

    Alarms are turned ON. The alarms include a dim light and soft buzz every twenty minutes during waking hours.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Alarms ONExperimental treatment 1 intervention
Group B: Alarms OFFNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Median IS breaths per hour

Median adequate IS breaths per hour within eligible hours of all patients in each reminder group

Time frame
Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)

Secondary outcomes

Other outcomes

1

Hypoxemia

Hypoxemia will be calculated using the trapezoidal rule when PaO₂/FiO₂ \< 300. The total time with hypoxemia for each POD will be observed using the area-under-curve (AUC); i.e., the use of the area under the oxygen saturation curve

Time frame
From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: