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Using Digitalized Incentive Spirometers to Assist Postoperative Rehabilitation of Abdominal Surgery Patients

Using Wireless Transformation of Portable Three-ball Incentive Spirometers to Assist the Record of Postoperative Rehabilitation and Pulmonary Function Change in Patients Undergoing Abdominal Surgery

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06132100
Enrollment
200
Registered
2023-11-15
Start date
2023-12-31
Completion date
2026-12-31
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Sleep Apnea, Obstructive

Keywords

bariatric surgery, incentive spirometry

Brief 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.

Detailed 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.

Interventions

DEVICEdigitalized incentive spirometry

digitalized incentive spirometry

DEVICEtraditional incentive spirometry

traditional incentive spirometry

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and outcomes assessor did not know the allocation of participant.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Patients undergoing bariatric surgery * 2\. Patients could cooperate with conducting incentive spirometry before and after the operation.

Exclusion criteria

* 1\. Patients with contra-indication for incentive spirometry. * 2\. Patients could not deeply breathe with pulmonary vital capacity less than 10mL/kg. * 3\. Patients could not cooperate with conducting incentive spirometry before and after the operation. * 4\. Other causes judged by the Principal Investigator

Design outcomes

Primary

MeasureTime frameDescription
Apnea/Hyponea Index7 - 10 daysPost operative
Pulse oximetry change7 - 10 daysPost operative

Secondary

MeasureTime frameDescription
Postoperative pulmonary complication7-10 daysincluding atelectasis, pneumonia and respiratory failure

Contacts

Primary ContactShih-Chiang Shen, MD
shsich@gmail.com886-2-22490088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026