Comparing Use of Incentive Spirometry With and Without Reminder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTidal Medical Technologies

About this trial

This study is designed to determine if patients using an incentive spirometer with visual and auditory signals will increase their use of the incentive spirometer and prevent lung complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has undergone a qualifying surgical procedure.

Patient is aged 18 years or over.

Patient has incentive spirometry ordered or incentive spirometry must be part of the study site's standard of care which is implemented by hospital staff.

Patient is able to comply with all study required incentive spirometry instructions.

Disqualifiers

Vulnerable Populations (Pregnant, minors, prisoners, those with significantly reduced mental acuity).

Patients where incentive spirometry is inappropriate (patients with Tractotomy, patients who are hemodynamically unstable, patients in reverse isolation due to infection).

Patients with a history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.

Any medical condition that, in the opinion of the investigator, would place the patient at increased risk if they participated.

Trial population

Post Operative Inpatients prescribed incentive spirometry.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Signal On

    Device

    InSee monitor patient signals are on.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Signal On1 intervention
Group B: Signal Off0 interventions

Trial outcomes

Primary outcomes

1

Number of successful inspiratory breaths attempts per day.

successful inspiratory breaths is defined as achieving the goal tidal volume

Time frame
through hospitalization an average of 5 days
2

Total number of inspiratory breaths achieved per day.

Inspiratory breaths while using the incentive spirometer

Time frame
throughout hospitalization an average of 5 days

Secondary outcomes

1

Time to achieve goal tidal volume.

Time in to achieve prescribed goal inspiratory tidal volume.

Time frame
throughout hospitalization an average of 5 days
2

Post operative length of O2 use.

Length of time from surgery until 02 is discontinued.

Time frame
throughout hospitalization an average of 5 days
3

Change in 02 flow rate.

Change in 02 flow rate delivered to the patient.

Time frame
throughout hospitalization an average of 5 days
4

inpatient Pulmonary complication rates.

Pulmonary complications during hospitalization

Time frame
throughout hospitalization an average of 5 days

Other outcomes

1

Intubation due to a respiratory diagnosis

Postoperative Intubation due to a respiratory diagnosis during hospitalization

Time frame
throughout hospitalization an average of 5 days
2

Reintubation due to a respiratory diagnosis

Reintubation due to a respiratory diagnosis during hospitalization

Time frame
throughout hospitalization an average of 5 days
3

ICU length of stay

Postoperative length of stay in ICU

Time frame
throughout hospitalization an average of 5 days
4

Inpatient hospital length of stay

Postoperative length of stay in hospital

Time frame
throughout hospitalization an average of 5 days

Sponsors and contacts

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