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NCT Number: NCT06101030

Comparing Use of Incentive Spirometry With and Without 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tidal Reseach Site, Silver Spring, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

Signal On

Device

InSee monitor patient signals are on.

Primary outcomes

  1. 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

  2. Total number of inspiratory breaths achieved per day.

    Time frame: throughout hospitalization an average of 5 days

    Inspiratory breaths while using the incentive spirometer

Secondary outcomes

  1. Time to achieve goal tidal volume.

    Time frame: throughout hospitalization an average of 5 days

    Time in to achieve prescribed goal inspiratory tidal volume.

  2. Post operative length of O2 use.

    Time frame: throughout hospitalization an average of 5 days

    Length of time from surgery until 02 is discontinued.

  3. Change in 02 flow rate.

    Time frame: throughout hospitalization an average of 5 days

    Change in 02 flow rate delivered to the patient.

  4. inpatient Pulmonary complication rates.

    Time frame: throughout hospitalization an average of 5 days

    Pulmonary complications during hospitalization

  5. Hospital discharge on O2.

    Time frame: throughout hospitalization an average of 5 days

    If a study patient is discharged on 02.

  6. Changes in Inspiratory volume.

    Time frame: throughout hospitalization an average of 5 days

    Changes (- or +) in the inspiratory volume a patient is able to achieve.

  7. Change in Inspiratory volume.

    Time frame: throughout hospitalization an average of 5 days

    Postoperative change in inspiratory volume

  8. Readmission for pulmonary complication

    Time frame: 30 days after discharge

    Readmission for pulmonary complication up to 30 days after hospital discharge

Other outcomes

  1. Intubation due to a respiratory diagnosis

    Time frame: throughout hospitalization an average of 5 days

    Postoperative Intubation due to a respiratory diagnosis during hospitalization

  2. Reintubation due to a respiratory diagnosis

    Time frame: throughout hospitalization an average of 5 days

    Reintubation due to a respiratory diagnosis during hospitalization

  3. ICU length of stay

    Time frame: throughout hospitalization an average of 5 days

    Postoperative length of stay in ICU

  4. Inpatient hospital length of stay

    Time frame: throughout hospitalization an average of 5 days

    Postoperative length of stay in hospital

  5. Change in SP02

    Time frame: throughout hospitalization an average of 5 days

    Postoperative Change in SP02

Study contacts

Contact information is provided by the study sponsor or research team.

Mehdi Arani

CONTACT

[email protected]

Michael Martin, RN

CONTACT

[email protected]

18582121728

Sponsors and collaborators

Lead sponsor

Tidal Medical Technologies

Industry

Registry information

Official study title

Comparing Post Operative Utilization of Incentive Spirometry With and Without Electronic Patient Reminder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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