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

NCT ID: NCT06132100

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2026-12-31

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.

Conditions

Bariatric Surgery Candidate; Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

traditional incentive spirometry

patients with traditional incentive spirometry

Group Type: PLACEBO_COMPARATOR

traditional incentive spirometry

Intervention Type: DEVICE

traditional incentive spirometry

digitalized incentive spirometry

patients with digitalized incentive spirometry

Group Type: EXPERIMENTAL

digitalized incentive spirometry

Intervention Type: DEVICE

digitalized incentive spirometry

Interventions

digitalized incentive spirometry

digitalized incentive spirometry

Intervention Type: DEVICE

traditional incentive spirometry

traditional incentive spirometry

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShihChiang Shen

Visiting staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shih-Chiang Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Shung-Ho Hospital

Central Contacts

Shih-Chiang Shen, MD

Role: CONTACT

shsich@gmail.com

886-2-22490088 ext. 8123

Other Identifiers

N202303047

Identifier Type: -

Identifier Source: org_study_id