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Recruiting NCT06101030

Comparing Use of Incentive Spirometry With and Without Reminder

Observational Post Operative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Signal On.
Who it may be relevant to
Registry conditions: Post Operative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Signal On
    InSee monitor patient signals are on.

Primary outcome measures

  • Number of successful inspiratory breaths attempts per day. [Time frame: through hospitalization an average of 5 days]
  • Total number of inspiratory breaths achieved per day. [Time frame: throughout hospitalization an average of 5 days]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 3 centers
  • Tidal Reseach Site — Silver Spring
  • Tidal Study Site — Rochester
  • Tidal Study Site — New Brunswick

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. PMID 29362219
  • Sweity 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. PMID 34429138
  • Alwekhyan 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. PMID 34676618

Identifiers

NCT: NCT06101030 · InSee 202301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗