Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06132100 |
Other study ID # |
N202303047 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2023 |
Est. completion date |
December 2026 |
Study information
Verified date |
November 2023 |
Source |
Taipei Medical University Shuang Ho Hospital |
Contact |
Shih-Chiang Shen, MD |
Phone |
886-2-22490088 |
Email |
shsich[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this clinical trial is to use a digital recording device integrated with an
incentive spirometer to record a patient's deep breathing lung training following abdominal
surgery. Through this digital recording, it will be possible to effectively assess the daily
frequency, duration, depth of deep breaths, and the volume of inhalation performed by the
patient during their breathing exercises. This will transform the previously
difficult-to-describe deep breathing training into a digital record, allowing healthcare
professionals to quickly evaluate the patient's condition. Patients can also monitor their
own respiratory function changes, leading to positive health promotion benefits, accelerating
their postoperative recovery, and simultaneously reducing healthcare costs and improving
medical quality.
Description:
After thoracoabdominal and neurosurgery procedures, an incentive spirometer is commonly
employed for deep breathing exercises to prevent or improve potential postoperative pulmonary
atelectasis, increase lung capacity, promote the clearance of respiratory secretions, and
maintain chest mobility to reduce postoperative complications related to lung collapse. This
medical device and the respiratory training process are essential components of Enhanced
Recovery After Surgery (ERAS) protocols, which integrate postoperative care processes to
enhance recovery, reduce hospitalization times, and minimize postoperative complications.
Currently, clinical guidelines typically recommend patients to perform 200-600 deep
inhalations per day after surgery. Despite the simplicity and effectiveness of using an
incentive spirometer for deep breathing exercises, the observation of patients' usage,
recording of the number and duration of exercises, and tracking of their deep inhalation
volumes have become crucial tasks for respiratory therapists, nurses, and physicians in the
postoperative setting, consuming significant time and resources.
Generally, using an incentive spirometer requires patients to perform 200-600 deep breaths a
day. According to a 2018 medical literature estimate in the United States, approximately 9.7
million surgical procedures annually involve the use of incentive spirometers, with human
resource costs for assisting patients in their use and assessing the effectiveness of their
pulmonary rehabilitation reaching approximately one billion US dollars.