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NCT Number: NCT03569332

Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)

This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Half of participants will receive the mobile self-input tool providing alarm, and their practicing rate will be sent to Nurse's Dashboard. While the other half will receive the mobile self-input tool, but it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Gangnam, 06351, South Korea

About this study

  • Background : Active respiratory therapy like incentive spirometer is needed to prevent pulmonary complications for patients undergoing post-operative under general anesthesia. But in many cases, patients don't practicing it for their pain, or they just forget doing it. And medical staffs are having difficulties in checking how well the patients follow the directions for doing incentive spirometer. Insufficient practicing incentive spirometer and deep breathing cause delay their health recovery.

Therefore, we want to make some tools which can encourage the patients' practicing for incentive spirometer and also supply the objective achievement of patients to medical staffs.

  • Objective : This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia.
  • Design: RCT (randomized controlled trial)
  • Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center
  • Enrollment : 44 patients undergoing gastrectomy.
  • Intervention 6-1) For study group : participants on study group are received self-input tool with alarm system on tablet.

Alarm is provided only if insufficient practice (less than 10 times/hour) from 9am to 9pm. The practicing rate is sent to Nurse's Dashboard.

6-2) For control group : participants on control group are received self-input tool without alarm on tablet. Their practicing rate is not sent to Nurse's Dashboard.

  • Scoring by practicing incentive spirometer from 9 am to 9 pm. (Only when a subject practiced more than 10 times per hour, the subject get 10 points) (Full score 240)
  • Study period : for 48hrs from one day to 3rd day after patient's operation
  • Satisfaction survey (SUS) after study(3rd day after operation)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A subject undergoing total gastrectomy or subtotal gastrectomy by robotic surgery, laparoscopic surgery or open surgery
  • A subject who got surgery under general anesthesia
  • A Subject receiving a prescription of using incentive spirometer
  • A subject who voluntarily agrees and signs

Exclusion criteria

  • Disorientation
  • Unscheduled emergency surgery
  • a subject who has difficulty in active breathing exercise due to problems such as heart disease, brain disease, chronic lung disease, etc.

Treatment and study plan

Alarm

Other
  • Alarm is provided from 9am to 9pm.
  • Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied.

Nurse's dashboard

Other
  • Wireless data transmission system
  • The practicing rate of participants on study group is sent to Nurse's Dashboard.
  • It is only to display.

Primary outcomes

  1. Total number of practicing incentive spirometer that subjects input by themselves on the mobile self-input tool and scoring by practicing incentive spirometer from 9 am to 9 pm.

    Time frame: Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.

    Only when a subject practiced more than 10 times per hour, the subject get 10 points

Secondary outcomes

  1. Collecting subject's medical records related to pulmonary complication

    Time frame: From one day after subject's operation to the date the subject leaves(discharges) the hospital. (Average duration is for 4~5days)

    such as body temperature, laboratory results and Chest X-ray.

  2. Satisfaction Survey for mobile self-input tool

    Time frame: 3rd day after operation

    Scoring by the answers of the Questionnaire of Satisfaction (SUS)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Jul 17, 2018

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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