Post OperativeNCT06101030
Comparing Use of Incentive Spirometry With and Without Reminder
An observational study of Post Operative, run by Tidal Medical Technologies at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative
- What is being tested?
- Signal On
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jan 2024to 7 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post Operative Inpatients prescribed incentive spirometry.
Who may be able to join
- Patients must meet all the following Inclusion criteria to be eligible for participation in the study:
- 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.
- Patient is without severe hearing or impaired visual acuity deficiency such that they cannot hear or see the audible and visual signal for the InSee monitor.
Who cannot join
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- 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.
- Any Physician determination that the patient should not participate.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mehdi Arani contact
United States3 sites, 2 recruiting
- Recruiting
Tidal Study Site
New Brunswick, New Jersey, 08901
Brian Raffel, DO
- Recruiting
Tidal Study Site
Rochester, Minnesota, 55905
William LeTourneau
- Terminated
Tidal Reseach Site
Silver Spring, Maryland, 20904
About this study
Official title: Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder
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.
Read the detailed description
The purpose of this study is to determine if the frequency of patients' use of physician ordered incentive spirometry increases with visual and auditory electronic encouragement (signals) compared to the no signal cohort.
Secondarily this study will correlate short term outcomes of study patients to known short term outcome data from the study site and published data to determine if there is a relationship between frequency of use and positive or outcomes or complications, as cited by peer reviewed literature.
- Conditions
- Post Operative
- Being tested
- Signal On
- Keywords
- Incentive spirometry, Post Operative, compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal OnDevice
InSee monitor patient signals are on.
| Study group | Role | What they receive |
|---|---|---|
| Signal On | Patient Signals ON Receives: Device: Signal On | |
| Signal Off | Patient Signals Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful inspiratory breaths attempts per day.
successful inspiratory breaths is defined as achieving the goal tidal volume
Measured: through hospitalization an average of 5 days
Total number of inspiratory breaths achieved per day.
Inspiratory breaths while using the incentive spirometer
Measured: throughout hospitalization an average of 5 days
Secondary outcomes (8)
Time to achieve goal tidal volume.
Time in to achieve prescribed goal inspiratory tidal volume.
Measured: throughout hospitalization an average of 5 days
Post operative length of O2 use.
Length of time from surgery until 02 is discontinued.
Measured: throughout hospitalization an average of 5 days
Change in 02 flow rate.
Change in 02 flow rate delivered to the patient.
Measured: throughout hospitalization an average of 5 days
inpatient Pulmonary complication rates.
Pulmonary complications during hospitalization
Measured: throughout hospitalization an average of 5 days
Hospital discharge on O2.
If a study patient is discharged on 02.
Measured: throughout hospitalization an average of 5 days
Changes in Inspiratory volume.
Changes (- or +) in the inspiratory volume a patient is able to achieve.
Measured: throughout hospitalization an average of 5 days
Change in Inspiratory volume.
Postoperative change in inspiratory volume
Measured: throughout hospitalization an average of 5 days
Readmission for pulmonary complication
Readmission for pulmonary complication up to 30 days after hospital discharge
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start16 Jan 2024
- Primary completion3 Sep 2025 (estimated)
- Study completion7 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post OperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tidal Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Study Director, M.D., Study director, Tidal Medical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101030
- Sponsor's protocol ID
- InSee 202301
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23.
PubMed 29362219Sweity EM, Alkaissi AA, Othman W, Salahat A. Preoperative incentive spirometry for preventing postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective, randomized controlled trial. J Cardiothorac Surg. 2021 Aug 24;16(1):241. doi: 10.1186/s13019-021-01628-2.
PubMed 34429138Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.
PubMed 34676618
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder
- ClinicalTrials.gov ID
- NCT06101030
- Acronym / sponsor ID
- InSee 202301
- Conditions
- Post Operative
- Keywords
- Incentive spirometry, Post Operative, compliance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tidal Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 7 Sep 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine if the frequency of patients' use of physician ordered incentive spirometry increases with visual and auditory electronic encouragement (signals) compared to the no signal cohort.
Secondarily this study will correlate short term outcomes of study patients to known short term outcome data from the study site and published data to determine if there is a relationship between frequency of use and positive or outcomes or complications, as cited by peer reviewed literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Signal On | – | Device: Signal OnPatient Signals ON |
| Signal Off | – | –Patient Signals Off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post Operative Inpatients prescribed incentive spirometry.
Key inclusion criteria (6 listed)
- Patients must meet all the following Inclusion criteria to be eligible for participation in the study:
- 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.
Key exclusion criteria (6 listed)
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signal OnInSee monitor patient signals are on. | Device | Signal On |
Primary outcome
Number of successful inspiratory breaths attempts per day.
Time frame: through hospitalization an average of 5 days
successful inspiratory breaths is defined as achieving the goal tidal volume
Total number of inspiratory breaths achieved per day.
Time frame: throughout hospitalization an average of 5 days
Inspiratory breaths while using the incentive spirometer
8 secondary outcomes
Time to achieve goal tidal volume.
Time frame: throughout hospitalization an average of 5 days
Post operative length of O2 use.
Time frame: throughout hospitalization an average of 5 days
Change in 02 flow rate.
Time frame: throughout hospitalization an average of 5 days
inpatient Pulmonary complication rates.
Time frame: throughout hospitalization an average of 5 days
Hospital discharge on O2.
Time frame: throughout hospitalization an average of 5 days
Changes in Inspiratory volume.
Time frame: throughout hospitalization an average of 5 days
Change in Inspiratory volume.
Time frame: throughout hospitalization an average of 5 days
Readmission for pulmonary complication
Time frame: 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 29362219Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23.
- Background: PubMed 34429138Sweity EM, Alkaissi AA, Othman W, Salahat A. Preoperative incentive spirometry for preventing postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective, randomized controlled trial. J Cardiothorac Surg. 2021 Aug 24;16(1):241. doi: 10.1186/s13019-021-01628-2.
- Background: PubMed 34676618Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehdi Arani contact
Hassan Study Director, M.D. study director
Tidal Medical Technologies
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative, run by Tidal Medical Technologies at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Martin, RN (18582121728, michael@tidalmed.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful inspiratory breaths attempts per day. (time frame: through hospitalization an average of 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.