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Evaluating the Effectiveness of Incentive Spirometry

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Lifespan

Status

Completed

Conditions

Oxygen Saturation
FEV1
Nursing Workload
Atelectasis
Respiratory Rate
FVC
Re-intubation
Incentive Spirometry
Dyspnea
Hospital Length of Stay
Oxygen Requirements
Pneumonia

Treatments

Behavioral: Use-recording, patient-reminder alarm for incentive spirometry

Study type

Interventional

Funder types

Other

Identifiers

NCT02952027
Lifespan

Details and patient eligibility

About

Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies.

The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergoes any cardiothoracic surgery
  • Is transferred to the cardiothoracic surgery intermediate (step-down) unit at Rhode Island Hospital
  • Already prescribed an incentive spirometer as standard-of-care
  • Followed by any healthcare provider
  • Ability to sign informed consent and comply with all study procedures including follow-up for up to 1 year

Exclusion criteria

  • <18 years of age
  • Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups, including a placebo group

Bell On
Experimental group
Description:
Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.
Treatment:
Behavioral: Use-recording, patient-reminder alarm for incentive spirometry
Bell Off
Placebo Comparator group
Description:
Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage
Treatment:
Behavioral: Use-recording, patient-reminder alarm for incentive spirometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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